Breastfeeding Infants Receiving Respiratory Support Trial

NCT02999165 | Terminated

• 1 other identifier: 16/WS/0142
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breastfeeding; CPAP; Humidified High Flow Nasal Cannula Oxygen; preterm neonate

Outcome Measures

Primary Outcomes (4)

• Incidence of episodes of desaturation during a feeding episode

  During a feeding episode physiological parameters (heart rate, respiratory rate, oxygen saturation) will be observed continuously using Massimo monitors and recorded every 5 minutes. Any episodes of desaturation will be recorded (duration of time that saturations under 92% and lowest recorded saturations).

  30 minutes

• Incidence of episodes of bradycardia during a feeding episode

  During a feeding episode physiological parameters (heart rate, respiratory rate, oxygen saturation) will be observed continuously using Massimo monitors and recorded every 5 minutes. Any episodes of bradycardia during a feeding episode will be recorded (duration that heart rate is less than 100 beats per minute and lowest recorded heartrate).

  30 minutes

• Incidence of episodes of apnoea during a feeding episode

  During a feeding episode physiological parameters (heart rate, respiratory rate, oxygen saturation) will be observed continuously using a Massimo monitor and recorded every 5 minutes. Any episodes of apnoea during a feeding episode will be recorded (duration of apnoea).

  30 minutes

• Incidence of episodes of temperature instability during a feeding episode

  Temperature will be recorded at beginning and end of a feeding episode (in degrees celsius). Any episodes of temperature instability during a feeding episode will be recorded.

  30 minutes

Secondary Outcomes (2)

• Breastfeeding behaviours displayed measured using the PIBBS scale

  30 minutes

• Parental perception of breast feeding an infant receiving respiratory support

  One week

Other Outcomes (2)

• Gestational age at full oral feeding

  Through study completion, an average of six months

• Route of oral feeding at discharge

  Through study completion, an average of six months

Study Arms (2)

CPAP group

25 infants undergoing treatment with continuous nCPAP who are making attempts at breast feeding and receiving nasogastric feeds.

Other: Breast feeding; Other: Nasogastric feeding

HHFNC group

25 infants undergoing treatment with continuous HHFNC oxygen who are making attempts at breast feeding and receiving nasogastric feeds.

Other: Breast feeding; Other: Nasogastric feeding

Interventions

Breast feeding OTHER

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

CPAP group; HHFNC group

Nasogastric feeding OTHER

The control intervention is feeding via nasogastric tube

CPAP group; HHFNC group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infants requiring medical care on a neonatal unit who are receiving continuous treatment with nCPAP or HHFNC and are making attempts to breast feed

You may qualify if:

• Infants cared for at Imperial College Healthcare NHS trust neonatal unit at Queen Charlottes and Chelsea Hospital and St Marys Hospital. Infants will be eligible if they are over 30 weeks of gestational age and receive continuous treatment with nCPAP or HHFNC .

You may not qualify if:

• Major congenital malformation or underlying genetic disorder
• signs of severe progressive respiratory distress
• FiO2 \> 0.4
• PCo2 \> 9kPa
• Need for high CPAP \> 8cmH2O
• Need for HHFNC with flow rate of \>8litres/min
• Severe temperature instability, not tolerating 30 min outside the incubator
• CPAP or HHFNC treatment stopped

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (1)

Queen Charlotte's and Chelsea Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Breast Feeding; Premature Birth

Interventions

Lactation

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Alexander Rakow, MD

  Imperial College NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: December 21, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)