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Breastfeeding Infants Receiving Respiratory Support Trial

NCT02999165 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2019-04-11

No results posted yet for this study

Summary

The purpose of this study is to assess whether two methods of breathing support in babies called 'Humidified High-Flow Nasal Cannula' oxygen (HHFNC) and 'nasal Continuous Positive Airways Pressure' (nCPAP) are compatible with breastfeeding. Many babies who are premature or unwell after birth require help with their breathing. This is often achieved by blowing a continuous flow of air through the nose and down into the lungs in order to reduce the amount of effort the baby needs to inflate the lungs during breathing.

Currently some centres allow babies to breastfeed whilst undergoing breathing support whilst other centres do not in case there is an increased risk of choking or other harmful events. In the latter case, babies are fed using a nasogastric tube (NGT) that runs from the baby's nostrils into their stomach.

At this centre, babies are allowed to breastfeed whilst simultaneously on either HHFNC or nCPAP. This is because the concerns over the choking risk are not evidence based. This study aims to conclusively prove that thisfeeding protocol is safe and then to expand into other areas of research to find out the following:

* Whether breastfeeding during nCPAP or HHFNC leads to babies establishing full breastfeeding sooner (and subsequently reduce the length of their stay in hospital)
* What the effects of breastfeeding of nCPAP or HHFNC are on a baby's parents (e.g. whether it enhances bonding)
* If nCPAP and HHFNC have different effects on breastfeeding As part of this study the investigators will observe stable babies on nCPAP or HHFNC during breastfeeding episodes. The investigators will monitor the babies for signs of distress or instability and whether they are more stable when breastfeeding is not occurring. This will be compared to an episode where the same baby is fed by NGT to see which technique is better.

Conditions

  • Intensive Care, Neonatal
  • Neonatal Respiratory Distress Syndrome
  • Continuous Positive Airway Pressure
  • Breast Feeding
  • Infant, Premature

Interventions

OTHER

Breast feeding

Infants on respiratory support will be allowed to attempt to breast feed (with a top up nasogastric tube feed if required).

OTHER

Nasogastric feeding

The control intervention is feeding via nasogastric tube

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Alexander Rakow, MD · Imperial College NHS Trust

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02999165 on ClinicalTrials.gov