Multicentre open label, pragmatic randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress
To investigate whether, in later preterm and early term infants with respiratory distress, the early use of surfactant, versus expectant management, results in shorter duration of hospital stay and fewer babies who fail to respond to treatment.
neoGASTRIC: Avoiding Routine Gastric Residual Volume Measurement in Neonatal Critical Care, a Multi-centre Randomised Controlled Trial
About one in seven babies born in the UK each year need specialist neonatal care in a hospital because they are born too early, are born very small or have a medical condition. Ensuring these babies have enough nutrition is a key part of their care. Premature babies are fed milk every few hours through a soft plastic tube into their stomach, called a gastric tube. As their stomachs and digestive systems are not yet ready for lots of milk, the amount given each feed is increased slowly. Some doctors and nurses regularly check how much milk is left in a baby's stomach, called 'routinely measuring gastric residual volumes'. They check because they believe it will help them know how the baby is coping with the milk feeds and they also think it may help to identify a severe disease called necrotising enterocolitis. However, others think measuring gastric volumes may be bad for babies and that it is inaccurate, uncomfortable for the baby and may actually be harmful. We want to answer the question: Is routinely measuring gastric residual volumes good or bad for babies?
This is an opt-out research trial, designed to be as simple as possible for families - you will be presented with an information sheet if eligible, and if you would like to discuss this further with the research team please call 0151 702 4084.
DOLFIN - Developmental Outcomes of Long Term Feed Supplementation in Neonates
This study is designed to test whether adding a daily nutrient supplement (food substance) to the normal milk and weaning foods of babies born with Hypoxic Ischaemic Encephalopathy (where the brain did not receive enough oxygen around time of birth) or babies born premature (born less than 28 weeks of gestation) can help improve their neurological development in later childhood (such as how they think, play and interact with others). The supplement contains substances that occur naturally in a healthy diet (and are often used as food supplements). Babies will be randomly allocated to receive supplement or a substance that looks the same (placebo).Supplement will be given twice a day mixed with a baby's normal milk or weaning foods until the baby is one year of age. Parents will be supported by hospital staff. Parents will also be asked to complete questionnaires at NNU discharge, 6, 12, 18, and 24 months about family circumstances, quality of life and their child's neurological development.
A small study has been carried out in the UK and the results were promising, but we need to find out more. We are aiming to include about 1,010 babies in order to be confident of finding out whether the supplement improves babies neurological development, or not. If the study tells us the supplement is effective, it might be given to babies as part of usual NHS care in the future.
If you would like to learn more about this study, please contact the neonatal research team on 0151 702 4084.
WithHolding Enteral Feeds Around Blood Transfusion (WHEAT International Trial)
The WHEAT International trial will compare two different approaches, feeding babies or not feeding babies during blood transfusions, to work out which one is better. Both approaches are standard practice in the UK but we don’t know how best to feed babies during blood transfusions – some hospitals and doctors stop feeds while others don’t. This is important because babies that are born early often need blood transfusions because they become anaemic (they do not have enough red blood cells, which can cause weakness or breathlessness). We know babies need blood transfusions, but we do not know how best to look after them during the transfusion.
Can the diagnostic accuracy of newborn eye screening for congenital cataract be improved with digital imaging? The Digital Imaging versus Ophthalmoscopy (DIvO) study.
Cataract (cloudiness of the lens) is the major cause of avoidable child blindness in the world and affects 1 in 3000 UK infants. Cataracts are present in both eyes in more than half of the babies affected. All UK babies are examined (screened) for cataract twice within the first 8 weeks of life. This study aims to test if screening using a new hand-held digital imaging device (Neocam) is more accurate than the ophthalmoscope for newborn eye screening.
You may be approached for DiVO after giving birth, before or after your newborn's first cataract screening. For more information please contact the research midwives at 0151 702 4355, or research.midwives@lwh.nhs.uk
A Phase 2b, Multicenter, Randomized, Open-label, Two‑Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity.
Babies born prematurely often have problems with their lungs and breathing immediately after birth and after they go home from hospital. This study is investigating if a drug called mecasermin rinfabate (OHB-607) can decrease the risk of breathing problems and lung disease, in particular bronchopulmonary dysplasia (BPD).
If you are interested in learning more or taking part in the study, please contact the research team at research@lwh.nhs.uk or on 0151 702 4084