Breast Feeding Clinical Trial
— BIRRSTOfficial title:
Breastfeeding Infants Receiving Respiratory Support Trial
NCT number | NCT02999165 |
Other study ID # | 16/WS/0142 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | November 2017 |
Verified date | April 2019 |
Source | Imperial College Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 . Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Charlotte's and Chelsea Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gestational age at full oral feeding | The age at which each infant achieves full oral feeding will be documented | Through study completion, an average of six months | |
Other | Route of oral feeding at discharge | The route of oral feeding (i.e. bottle vs. breast feeding) at the time of discharge home will be recorded. | Through study completion, an average of six months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Breastfeeding behaviours displayed measured using the PIBBS scale | Efficacy of breast feeding will be assessed using the PIBBS scale (Premature Infant Breastfeeding Behaviours Scale) | 30 minutes | |
Secondary | Parental perception of breast feeding an infant receiving respiratory support | Parents will complete a questionnaire addressing parental perception of breastfeeding using a series of visual analogue scales. | One week |
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