Breastfeeding Infants Receiving Respiratory Support Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Incidence of episodes of apnoea during a feeding episode
研究概览
简要总结
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.
详细描述
BACKGROUND Breastfeeding infants receiving respiratory support (nCPAP or HHFNC) is a controversial topic. Expert consensus has been that feeding should be delayed until respiratory support (including nCPAP or HHFNC) is no longer needed. Data from animal models suggests that nasal CPAP can affect swallowing behaviour in infant animals but the magnitude and clinical significance of any effect is unclear even in animals. Studies in adults are also lacking but some have shown that swallowing can be impaired during CPAP therapy. There is no research into whether HHFNC has similar effects in any of the above populations. There is currently no published data on the safety or efficacy of breastfeeding infants receiving respiratory support via nasal CPAP or HHFNC.
nCPAP is a key intervention in the current care of many babies as it is the preferred mode of non-invasive respiratory support and compared to conventional mechanical ventilation it has been shown to reduce the incidence of bronchopulmonary dysplasia . HHFNC oxygen has emerged as another method of respiratory support. It has been shown that it is non-inferior to nCPAP following extubation although it is clear that the mechanics of flow delivery differ from nCPAP. There is some evidence that HHFNC use is associated with a reduction in some adverse effects when compared with nCPAP, such as nasal trauma.
Some infants, especially infants born very preterm, spend prolonged periods on nasal CPAP or HHFNC. Normal oral feeding is often delayed in these children because respiratory support is needed. It has been shown that premature infants can show breastfeeding cues from a very early stage and if infants are given the opportunity breastfeeding can be well established. Recent studies have shown that early introduction of oral feeding in preterm neonates is not associated with adverse outcomes and leads to earlier establishment of full oral feeding and discharge home.
RATIONALE FOR CURRENT STUDY There is uncertainty surrounding the safety of breastfeeding babies on nasal nCPAP or HHFNC. There is great disparity in clinical practice between neonatal units. At our department babies on respiratory support have traditionally been offered the chance to breastfeed. Local experience is that this is not associated with adverse events. When compared to other units internationally (as part of the Vermont-Oxford Network of neonatal units) our unit does not have an excess of complications due to this practice.
Establishing the safety of breastfeeding whilst receiving nCPAP or HHFNC will provide clinicians with the information necessary to decide when breastfeeding should be attempted in infants needing ongoing respiratory support.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 .
排除标准
- •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
结局指标
主要结局
Incidence of episodes of apnoea during a feeding episode
时间窗: 30 minutes
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).
Incidence of episodes of desaturation during a feeding episode
时间窗: 30 minutes
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).
Incidence of episodes of bradycardia during a feeding episode
时间窗: 30 minutes
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).
Incidence of episodes of temperature instability during a feeding episode
时间窗: 30 minutes
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.
次要结局
- Parental perception of breast feeding an infant receiving respiratory support(One week)
- Breastfeeding behaviours displayed measured using the PIBBS scale(30 minutes)