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

NCT03961139 | Unknown DMC

• 1 other identifier: 2018/00773
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chronic Lung Disease of Prematurity; Bronchopulmonary Dysplasia

Keywords

Prematurity; Randomised control trial (RCT); BPD; CLD; continuous feeding

Outcome Measures

Primary Outcomes (2)

• Incidence of BPD

  BPD as defined by 2001 NICHD criteria

  occurring before 36 weeks post menstrual age or 28 days of life

• Incidence of Death

  Death occurring before 36 weeks post menstrual age or 28 days of life

  occurring before 36 weeks post menstrual age or 28 days of life

Secondary Outcomes (7)

• Invasive Ventilatory requirements

  36 weeks post menstrual age or 28 days of life

• Any Ventilatory requirements

  36 weeks post menstrual age or 28 days of life

• Supplemental Oxygen support

  36 weeks post menstrual age or 28 days of life

• Feed tolerance

  36 weeks post menstrual age or 28 days of life

• Weight outcomes

  birth, 36 weeks and 40 weeks post menstrual age

Study Arms (2)

Continuous feeding (CF)

EXPERIMENTAL

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

Bolus feeding (BF)

ACTIVE COMPARATOR

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

Interventions

Method of feeding; continuous feeding OR bolus feeding OTHER

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.

Bolus feeding (BF); Continuous feeding (CF)

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Major congenital malformation
• Chromosomal abnormality
• minute Apgar score of =3
• Not expected to survive beyond 72 hours of age
• Bilateral grade 4 intraventricular haemorrhage (IVH)
• Did not consent / Consent not available

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (2)

NICU, Universiti Kebangsaan Malaysia

Kuala Lumpur, 56000, Malaysia

RECRUITING

NICU, National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Agnihotri Biswas, MRCPCH

  Senior Consultant Neonatologist, NUH Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnihotri Biswas, MRCPCH

CONTACT

+65 67725075; biswas_agnihotri@nuhs.edu.sg

Jiun Lee, MRCPCH

CONTACT

+65 67725076; lee_jiun@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: na. Open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 23, 2019
• Study Start: December 3, 2019
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 18, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); MY (1)