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出境医 / 临床实验 / Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants - Effect on Respiratory Morbidity (CONFER)

Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants - Effect on Respiratory Morbidity (CONFER)

Study Description
Brief Summary:

Chronic Lung Disease (CLD) of Prematurity is a common yet challenging co-morbidity affecting extremely premature newborns. Multifactorial influences leading to this co-morbidity is known and targeted in various research studies. Gastroesophageal reflux (GER) is common among the same cohort of patients. The investigators hypothesize that recurrent milk reflux into the airways of the premature babies worsen the inflammation of premature lungs and is a major contributor of CLD.

The investigators hypothesize that Continuous feeding (CF) minimises GER and micro-aspiration, thereby reducing the incidence and severity of CLD in high-risk infants.

Our aim is to compare the effect of intermittent bolus versus continuous intra-gastric feeding on the incidence and severity of CLD in very low birth weight infants ≤ 1250 grams.


Condition or disease Intervention/treatment Phase
Chronic Lung Disease of Prematurity Bronchopulmonary Dysplasia Other: Method of feeding; continuous feeding OR bolus feeding Not Applicable

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomised-controlled trial with 2 parallel groups (1:1 ratio). Control group: intermittent bolus intra-gastric tube feeding (BF), Intervention group: continuous intra-gastric tube feeding (CF). Not blinded.

Stratified randomization along following birth weight groups:

  1. </=750 g
  2. 751 - 1000 g
  3. 1001 -1250 g Method of randomisation: Computer generated randomization codes stored in sealed opaque envelopes.

Intervention started by 72 hours of life (more than trophic feed volume achieved) and continued until an infant reaches a weight of 1.6 kg and is determined by the attending Neonatologist to be ready to commence oral feeding by breast or bottle, or when an infant attains a post-conceptional age of 36 weeks, whichever is earlier.

Continuous fed is delivered through a nasogastric tube by a syringe pump over 3hrs with 1 hour of break - 6 cycles a day. Feed volume, type of feed, feed increment regulated by the clinical team.

Intention to treat analysis.
Masking: None (Open Label)
Masking Description: na. Open label
Primary Purpose: Prevention
Official Title: Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants - Effects on Respiratory Morbidity: A Multicentre Randomised Controlled Clinical Trial
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Continuous feeding (CF)

Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.

Feed volume increment per day is as per departmental protocol and same as comparator arm.

 Other: Method of feeding; continuous feeding OR bolus feeding

CF: Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.

BF: Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes.
Active Comparator: Bolus feeding (BF)

Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes.

Feed volume increment per day is as per departmental protocol and same as experimental arm.

 Other: Method of feeding; continuous feeding OR bolus feeding

CF: Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.

BF: Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes.
Outcome Measures
Primary Outcome Measures :
  1. Incidence of BPD [ Time Frame: occurring before 36 weeks post menstrual age or 28 days of life ]
    BPD as defined by 2001 NICHD criteria

  2. Incidence of Death [ Time Frame: occurring before 36 weeks post menstrual age or 28 days of life ]
    Death occurring before 36 weeks post menstrual age or 28 days of life


Secondary Outcome Measures :
  1. Invasive Ventilatory requirements [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on invasive ventilation

  2. Any Ventilatory requirements [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on any ventilatory (invasive or non invasive) support

  3. Supplemental Oxygen support [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on supplemental oxygen

  4. Feed tolerance [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Time (days) from randomization to achievement of full feeds (defined as 150ml/Kg/Day)

  5. Weight outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for weight (grams)

  6. Length outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for length (cm)

  7. Head Growth outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for head circumference (cm)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with a birth weight <1250g and a gestational age of between 24+0 - 33+6 weeks

Exclusion Criteria:

  1. Major congenital malformation
  2. Chromosomal abnormality
  3. 10-minute Apgar score of =3
  4. Not expected to survive beyond 72 hours of age
  5. Bilateral grade 4 intraventricular haemorrhage (IVH)
  6. Did not consent / Consent not available
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Agnihotri Biswas, MRCPCH +65 67725075 biswas_agnihotri@nuhs.edu.sg
Contact: Jiun Lee, MRCPCH +65 67725076 lee_jiun@nuhs.edu.sg

Locations
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Malaysia
NICU, Universiti Kebangsaan Malaysia Recruiting
Kuala Lumpur, Malaysia, 56000
Contact: Fook-Choe Cheah, FRCPCH    +60 3 91456637    cheahfc@ppukm.ukm.edu.my   
Singapore
NICU, National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Agnihotri Biswas, MRCPCH    67725075    biswas_agnihotri@nuhs.edu.sg   
Contact: Jiun Lee, MRCPCH    67725075    lee_jiun@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Agnihotri Biswas, MRCPCH Senior Consultant Neonatologist, NUH Singapore
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE December 3, 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Incidence of BPD [ Time Frame: occurring before 36 weeks post menstrual age or 28 days of life ]
    BPD as defined by 2001 NICHD criteria
  • Incidence of Death [ Time Frame: occurring before 36 weeks post menstrual age or 28 days of life ]
    Death occurring before 36 weeks post menstrual age or 28 days of life
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Invasive Ventilatory requirements [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on invasive ventilation
  • Any Ventilatory requirements [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on any ventilatory (invasive or non invasive) support
  • Supplemental Oxygen support [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Days on supplemental oxygen
  • Feed tolerance [ Time Frame: 36 weeks post menstrual age or 28 days of life ]
    Time (days) from randomization to achievement of full feeds (defined as 150ml/Kg/Day)
  • Weight outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for weight (grams)
  • Length outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for length (cm)
  • Head Growth outcomes [ Time Frame: birth, 36 weeks and 40 weeks post menstrual age ]
    Z-scores for head circumference (cm)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants - Effect on Respiratory Morbidity
Official Title  ICMJE Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants - Effects on Respiratory Morbidity: A Multicentre Randomised Controlled Clinical Trial
Brief Summary

Chronic Lung Disease (CLD) of Prematurity is a common yet challenging co-morbidity affecting extremely premature newborns. Multifactorial influences leading to this co-morbidity is known and targeted in various research studies. Gastroesophageal reflux (GER) is common among the same cohort of patients. The investigators hypothesize that recurrent milk reflux into the airways of the premature babies worsen the inflammation of premature lungs and is a major contributor of CLD.

The investigators hypothesize that Continuous feeding (CF) minimises GER and micro-aspiration, thereby reducing the incidence and severity of CLD in high-risk infants.

Our aim is to compare the effect of intermittent bolus versus continuous intra-gastric feeding on the incidence and severity of CLD in very low birth weight infants ≤ 1250 grams.
Detailed Description

The pathogenesis of bronchopulmonary dysplasia (BPD) is complex and multifactorial. As a result of premature birth, developmental arrest during a critical period of fetal lung development compounded by mechanical, oxidative and other injuries sustained during neonatal respiratory care forms the basis of pathogenesis. BPD affects up to 50% of infants with birth weight less than 1000 g. Between 2000 and 2009, despite advancement of neonatal care, annual BPD rates reported by Vermont Oxford Network among very low birth weight infants varied from 26.2% to 30.4% without any decline. Severely affected infants often require prolonged ventilation, high oxygen use, alternative airway and several potent medications over the first few months to years of their lives. High mortality rates, neurodevelopmental delay, respiratory morbidity and growth failure are associated with BPD.

Treatment of severe BPD with or without pulmonary hypertension is challenging. Prolonging the pregnancy in the face of premature labour, treating perinatal infections, augmenting pulmonary maturity with corticosteroids, judicious oxygen use, lung protective ventilation and optimizing nutrition to promote growth are important and well established measures to prevent or modify the progress of the chronic lung disease.

It is common to find infants with BPD also having significant symptoms of reflux. Gastroesophageal reflux (GER) is a well-known co-morbidity among preterms and ex-preterms on chronic ventilation, many of whom go on to require surgical fundoplication to stop the reflux thus preventing further lung damage. Some have reported dramatic respiratory improvement after resolution of GER. In the early days of a preterm baby with respiratory distress, GER is common and silent. Among infants, diagnosis of pathologic GER from a benign one is difficult. Many neonatal intensive care units (NICUs) would investigate for GER only when faced with moderate to severe BPD to achieve better respiratory symptom control. However GER has not been studied well as a factor precipitating the development of BPD among VLBW neonates. This is the focus of the study.

Aspiration of gastric contents into the lung is a widespread phenomenon in mechanically ventilated preterm infants. In animal models of gastric aspiration, gastric particulates altered the pulmonary mechanics, increased pulmonary inflammatory cells, released pro-inflammatory mediators, and inactivated surfactant. Development of bacterial pneumonia is a well-recognized complication following aspiration of gastric contents. The investigators hypothesize that repeated aspirations would aggravate and accelerate an inflammatory response in the lung finally leading on to BPD. In addition oxygen mediated damage and mechanical ventilation potentiate lung injury due to aspiration. Logically, if GER and aspiration could be minimized, it could decrease the incidence and severity of BPD.

Certain positioning of the baby, small volume of feed increment, keeping a close watch on feed tolerance are practical ways of improving feeding tolerance and reducing GER. The intermittent bolus intra-gastric feeding method is commonly used to feed premature babies. Other alternatives are continuous intra-gastric (feed volume is slowly infused in the stomach over couple of hours through the nasogastric tube) and continuous transpyloric feeding (feeding tube passes beyond the stomach to the duodenum and feed volume is slowly infused over hours). Transpyloric continuous feeding as compared to intermittent gastric bolus feeding, has been found to significantly reduce ventilatory support requirements in extremely low birth weight (ELBW) infants, possibly via its effect of minimising GER. In this study, none of the babies who received transpyloric feeding developed significant BPD and in addition babies with significant BPD improved after switching to transpyloric method. Transpyloric feeding tubes however are challenging to insert, and intestinal perforation is an uncommon but significant adverse effect. This feeding method is also not physiological as it bypasses the stomach. It remains to be seen if continuous gastric feeds, which is easily administered and safer, would yield some of the advantages of continuous transpyloric feeds over intermittent gastric feeding.

A Cochrane review in 2011 of continuous intra-gastric versus intermittent bolus intra-gastric feeding for premature infants found conflicting results, and was unable to make recommendations regarding the benefits and risks of these feeding methods. Clinical outcomes of interest from these trials were related to growth, feeding tolerance and gastrointestinal complications. The Cochrane review importantly found no significant difference in somatic growth and incidence of necrotising enterocolitis (NEC) between either feeding methods. Another Cochrane review in 2014 did not identify any randomised trial that evaluated the effects of continuous versus intermittent bolus intragastric tube feeding on gastro-oesophageal reflux disease in preterm and low birth weight infants and opined that well-designed and adequately powered trials are needed in this field. There were no studies comparing the effect of the above feeding methods on respiratory outcomes either.

Trial objectives

Aim: To compare the effect of intermittent bolus versus continuous intra-gastric feeding on the incidence and severity of BPD in very low birth weight infants (≤ 1250 grams).

Hypothesis: Continuous feeding (CF) minimises silent GER and micro-aspiration, thereby reducing the incidence and severity of bronchopulmonary dysplasia (BPD) in high-risk infants when compared to intermittent bolus feeding (BF).

Statistical considerations

Sample size calculation: based on 2015 data from the Singapore National Very-Low-Birth-Weight (VLBW) Infant Network for infants ≤ 1250 grams, mortality rate was 12.9% and BPD rate (defined as any oxygen supplementation or any respiratory support at 36 weeks post-conceptional age) was 29.4%. Thus the composite primary outcome rate was 42.3%. For a primary outcome rate reduction from 45% to 22.5%, with a type 1 error rate of 5% and a power of 80%, a sample size of 68 infants in each arm is required, giving a total sample size of 136 infants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomised-controlled trial with 2 parallel groups (1:1 ratio). Control group: intermittent bolus intra-gastric tube feeding (BF), Intervention group: continuous intra-gastric tube feeding (CF). Not blinded.

Stratified randomization along following birth weight groups:

  1. </=750 g
  2. 751 - 1000 g
  3. 1001 -1250 g Method of randomisation: Computer generated randomization codes stored in sealed opaque envelopes.

Intervention started by 72 hours of life (more than trophic feed volume achieved) and continued until an infant reaches a weight of 1.6 kg and is determined by the attending Neonatologist to be ready to commence oral feeding by breast or bottle, or when an infant attains a post-conceptional age of 36 weeks, whichever is earlier.

Continuous fed is delivered through a nasogastric tube by a syringe pump over 3hrs with 1 hour of break - 6 cycles a day. Feed volume, type of feed, feed increment regulated by the clinical team.

Intention to treat analysis.

Masking: None (Open Label)
Masking Description:
na. Open label
Primary Purpose: Prevention
Condition  ICMJE
  • Chronic Lung Disease of Prematurity
  • Bronchopulmonary Dysplasia
Intervention  ICMJE Other: Method of feeding; continuous feeding OR bolus feeding

CF: Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.

BF: Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes.
Study Arms  ICMJE
  • Experimental: Continuous feeding (CF)

    Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.

    Feed volume increment per day is as per departmental protocol and same as comparator arm.

    Intervention: Other: Method of feeding; continuous feeding OR bolus feeding
  • Active Comparator: Bolus feeding (BF)

    Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes.

    Feed volume increment per day is as per departmental protocol and same as experimental arm.

    Intervention: Other: Method of feeding; continuous feeding OR bolus feeding
Publications *
  • Bancalari E, Claure N, Sosenko IR. Bronchopulmonary dysplasia: changes in pathogenesis, epidemiology and definition. Semin Neonatol. 2003 Feb;8(1):63-71. Review.
  • Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sánchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
  • Horbar JD, Carpenter JH, Badger GJ, Kenny MJ, Soll RF, Morrow KA, Buzas JS. Mortality and neonatal morbidity among infants 501 to 1500 grams from 2000 to 2009. Pediatrics. 2012 Jun;129(6):1019-26. doi: 10.1542/peds.2011-3028. Epub 2012 May 21.
  • Ehrenkranz RA, Walsh MC, Vohr BR, Jobe AH, Wright LL, Fanaroff AA, Wrage LA, Poole K; National Institutes of Child Health and Human Development Neonatal Research Network. Validation of the National Institutes of Health consensus definition of bronchopulmonary dysplasia. Pediatrics. 2005 Dec;116(6):1353-60.
  • Jobe AH. The new bronchopulmonary dysplasia. Curr Opin Pediatr. 2011 Apr;23(2):167-72. doi: 10.1097/MOP.0b013e3283423e6b. Review.
  • Cristea AI, Carroll AE, Davis SD, Swigonski NL, Ackerman VL. Outcomes of children with severe bronchopulmonary dysplasia who were ventilator dependent at home. Pediatrics. 2013 Sep;132(3):e727-34. doi: 10.1542/peds.2012-2990. Epub 2013 Aug 5.
  • Walsh MC, Morris BH, Wrage LA, Vohr BR, Poole WK, Tyson JE, Wright LL, Ehrenkranz RA, Stoll BJ, Fanaroff AA; National Institutes of Child Health and Human Development Neonatal Research Network. Extremely low birthweight neonates with protracted ventilation: mortality and 18-month neurodevelopmental outcomes. J Pediatr. 2005 Jun;146(6):798-804.
  • Khemani E, McElhinney DB, Rhein L, Andrade O, Lacro RV, Thomas KC, Mullen MP. Pulmonary artery hypertension in formerly premature infants with bronchopulmonary dysplasia: clinical features and outcomes in the surfactant era. Pediatrics. 2007 Dec;120(6):1260-9.
  • Radford PJ, Stillwell PC, Blue B, Hertel G. Aspiration complicating bronchopulmonary dysplasia. Chest. 1995 Jan;107(1):185-8.
  • Demirel G, Yilmaz Y, Uras N, Erdeve O, Ulu HO, Oguz SS, Dilmen U. Dramatical recovery of a mechanical ventilatory dependent extremely low birth weight premature infant after Nissen fundoplication. J Trop Pediatr. 2011 Dec;57(6):484-6. doi: 10.1093/tropej/fmq125. Epub 2011 Jan 19.
  • Gien J, Kinsella J, Thrasher J, Grenolds A, Abman SH, Baker CD. Retrospective Analysis of an Interdisciplinary Ventilator Care Program Intervention on Survival of Infants with Ventilator-Dependent Bronchopulmonary Dysplasia. Am J Perinatol. 2017 Jan;34(2):155-163. doi: 10.1055/s-0036-1584897. Epub 2016 Jun 29.
  • Newell SJ, Booth IW, Morgan ME, Durbin GM, McNeish AS. Gastro-oesophageal reflux in preterm infants. Arch Dis Child. 1989 Jun;64(6):780-6.
  • Ewer AK, Durbin GM, Morgan ME, Booth IW. Gastric emptying and gastro-oesophageal reflux in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1996 Sep;75(2):F117-21.
  • Peter CS, Sprodowski N, Bohnhorst B, Silny J, Poets CF. Gastroesophageal reflux and apnea of prematurity: no temporal relationship. Pediatrics. 2002 Jan;109(1):8-11.
  • López-Alonso M, Moya MJ, Cabo JA, Ribas J, del Carmen Macías M, Silny J, Sifrim D. Twenty-four-hour esophageal impedance-pH monitoring in healthy preterm neonates: rate and characteristics of acid, weakly acidic, and weakly alkaline gastroesophageal reflux. Pediatrics. 2006 Aug;118(2):e299-308. Epub 2006 Jul 10.
  • Fuloria M, Hiatt D, Dillard RG, O'Shea TM. Gastroesophageal reflux in very low birth weight infants: association with chronic lung disease and outcomes through 1 year of age. J Perinatol. 2000 Jun;20(4):235-9.
  • Jadcherla SR, Peng J, Chan CY, Moore R, Wei L, Fernandez S, DI Lorenzo C. Significance of gastroesophageal refluxate in relation to physical, chemical, and spatiotemporal characteristics in symptomatic intensive care unit neonates. Pediatr Res. 2011 Aug;70(2):192-8. doi: 10.1203/PDR.0b013e31821f704d.
  • Farhath S, He Z, Nakhla T, Saslow J, Soundar S, Camacho J, Stahl G, Shaffer S, Mehta DI, Aghai ZH. Pepsin, a marker of gastric contents, is increased in tracheal aspirates from preterm infants who develop bronchopulmonary dysplasia. Pediatrics. 2008 Feb;121(2):e253-9. doi: 10.1542/peds.2007-0056.
  • Knight PR, Davidson BA, Nader ND, Helinski JD, Marschke CJ, Russo TA, Hutson AD, Notter RH, Holm BA. Progressive, severe lung injury secondary to the interaction of insults in gastric aspiration. Exp Lung Res. 2004 Oct-Nov;30(7):535-57.
  • Davidson BA, Knight PR, Wang Z, Chess PR, Holm BA, Russo TA, Hutson A, Notter RH. Surfactant alterations in acute inflammatory lung injury from aspiration of acid and gastric particulates. Am J Physiol Lung Cell Mol Physiol. 2005 Apr;288(4):L699-708.
  • Nader-Djalal N, Knight PR, Davidson BA, Johnson K. Hyperoxia exacerbates microvascular lung injury following acid aspiration. Chest. 1997 Dec;112(6):1607-14.
  • Nader-Djalal N, Knight PR 3rd, Thusu K, Davidson BA, Holm BA, Johnson KJ, Dandona P. Reactive oxygen species contribute to oxygen-related lung injury after acid aspiration. Anesth Analg. 1998 Jul;87(1):127-33.
  • Hermon MM, Wassermann E, Pfeiler C, Pollak A, Redl H, Strohmaier W. Early mechanical ventilation is deleterious after aspiration-induced lung injury in rabbits. Shock. 2005 Jan;23(1):59-64.
  • Premji SS, Chessell L. Continuous nasogastric milk feeding versus intermittent bolus milk feeding for premature infants less than 1500 grams. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD001819. doi: 10.1002/14651858.CD001819.pub2. Review.
  • Richards R, Foster JP, Psaila K. Continuous versus bolus intragastric tube feeding for preterm and low birth weight infants with gastro-oesophageal reflux disease. Cochrane Database Syst Rev. 2014 Jul 17;(7):CD009719. doi: 10.1002/14651858.CD009719.pub2. Review.
  • de Ville K, Knapp E, Al-Tawil Y, Berseth CL. Slow infusion feedings enhance duodenal motor responses and gastric emptying in preterm infants. Am J Clin Nutr. 1998 Jul;68(1):103-8.
  • Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants with a birth weight <1250g and a gestational age of between 24+0 - 33+6 weeks

Exclusion Criteria:

  1. Major congenital malformation
  2. Chromosomal abnormality
  3. 10-minute Apgar score of =3
  4. Not expected to survive beyond 72 hours of age
  5. Bilateral grade 4 intraventricular haemorrhage (IVH)
  6. Did not consent / Consent not available
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Agnihotri Biswas, MRCPCH +65 67725075 biswas_agnihotri@nuhs.edu.sg
Contact: Jiun Lee, MRCPCH +65 67725076 lee_jiun@nuhs.edu.sg
Listed Location Countries  ICMJE Malaysia,   Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03961139
Other Study ID Numbers  ICMJE 2018/00773
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Agnihotri Biswas, MRCPCH Senior Consultant Neonatologist, NUH Singapore
PRS Account National University Hospital, Singapore
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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