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.
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
Parent co-Designed Drug Information for parents and Guardians Taking Neonates home (PADDINGToN 2) – a Feasibility Study. Some babies who have been on the neonatal unit (NNU) will be sent home with medicines. The PADDINGToN-1 study helped to develop resources to support parents with administering these medicines at home to their child. PADDINGToN-2 is a feasibility study to help answer questions about the usefulness of these resources, and see what the best way to collect information about parents’ anxiety and confidence around medications as well as how to keep a wide range of parents engaged and involved. If you have any further questions or would like to take part in the study, please contact the research team on 0151 702 4084.
Cooling in Mild Encephalopathy (COMET) trial. There is currently variation in practice in how to treat mild hypoxic ischaemic encephalopathy (HIE). Current standard of care is to offer whole body therapeutic hypothermia to infants with moderate and severe HIE, but it is not known if this is beneficial to infants with mild HIE. The COMET trial, a randomised controlled trial, will evaluate if it is better for a baby born at or after 36 weeks with mild HIE to be cooled or not, to standardise infant care. If you would like more information or to take part in the study, please contact the research team on 0151 702 4084.
Registry of Pulmonary Hypertension in Neonates. A secure web-based disease registry database is being compiled for neonates with pulmonary hypertension. This will help to develop a definitive neonatal pulmonary hypertension core outcome set, a classification system, and to characterise the incidence, demographics, predisposing factors, treatments and natural history of neonatal pulmonary hypertension. This registry also aims to identify risk factors for mortality and adverse long-term neurodevelopmental outcome in neonatal pulmonary hypertension. If you are interested in learning more or would like to take part in the study, please contact the research team on 0151 702 4084.