PREGNANCY & CHILDBIRTH
Trial name: FEED1
A randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30-33 weeks gestational age)
Contact:
Garry Meakin (Trial Manager) FEED1@nottingham.ac.uk
Useful links:
Randomisation system: https://ctu2.nottingham.ac.uk/1704/
eCRF system: https://macro02.nottingham.ac.uk/
Chief investigator:
Dr Shalini Ojha
Trial Description:
Around 8% of UK babies are born premature at birth and 12% of these are born between 30 and 33 weeks.
Currently,most preterm babies are fed through a drip into their veins (intravenous) and given small amounts of milk by a small tube into their stomach, slowly increasing until they are fully milk fed. Doctors are wary of feeding premature babies with full milk straight after birth due to a potentially life-threatening gut condition called necrotising enterocolitis (NEC). Evidence suggests that in premature babies who aren't too poorly, larger milk feeds can be successfully given within 48 hours of birth without increasing the risk of NEC and death, and could reduce the risk of severe infection.
We will compare the two different groups: the 'full milk' group will be given milk to provide all their fluid needs from the first day of life and increased over a few days unless they are struggling with this (e.g. if it makes them very sick). In the 'gradual milk' group, babies will be initially fed through their veins, increasing milk feeds slowly and reducing IV fluids until they are fully milk fed, which is current practice.
Mothers will be identified at Antenatal clinic or within 3 hours of early arrival. The groups will be decided at random by a computer giving each baby an equal chance of being in either group.
We want to know if feeding babies on with milk only from the first day of life, avoiding giving them fluids through a drip(IV), can reduce infections, reduce the number of days in hospital and therefore reduce the overall costs to parents and to the NHS.
Funding:
NIHR Health Technology Assessment
Status:
Recruiting
Further information:
ISRCTN reference number ISRCTN49639731 - http://www.isrctn.com/ISRCTN49639731
Trial name: GBS3
The clinical and cost-effectiveness of testing for Group B Streptococcus: a cluster randomised trial with economic and acceptability evaluations (GBS3)
Chief investigators:
Professor Jane Daniels (Non-Clinical)
Dr Kate Walker (Clinical)
Trial Description:
A multi-centre prospective two-arm parallel cluster randomised controlled superiority trial with internal pilot, feasibility evaluation, qualitative study and parallel economic modelling. The objective is to test whether routine testing of women for GBS (for Group B Streptococcus) colonisation either in late pregnancy or during labour reduces the occurrence of early-onset neonatal sepsis, compared to the current risk factor based strategy.
Funding:
NIHR Health Technology Assessment
Status:
Recruiting
Contact:
Sarah Craig (Trial Manager) sarah.craig1@nottingham.ac.uk
Further information:
GBS3@nottingham.ac.uk
ISRCTN reference number ISRCTN49639731 - http://www.isrctn.com/ISRCTN49639731
Trial Name: Do tests of placental function improve outcome for women with reduced fetal movements at 36 weeks gestation, or later? The REMIT-2 trial
Chief Investigator: Alexander Heazell, University of Manchester
Trial Description: In the UK, 1 in 220 babies are stillborn (born with no signs of life after 24 weeks of pregnancy). This is a higher proportion than in many other high income countries. Forty percent of babies who are stillborn die after 36 weeks of pregnancy and have no lethal structural abnormality. These deaths are tragedies for the families. If babies at a risk of stillbirth could be identified and delivered early, lives could be saved.
An association between the mother noticing reduced fetal movements and subsequent stillbirth has been documented for over 40 years. For women reporting reduced fetal movements at 36 weeks or later, standard care varies but usually includes assessment of the fetal heart rate with cardiotocography, and assessment of fetal growth and wellbeing by ultrasound scan and umbilical artery doppler. The aims of this trial were to assess whether using tests to measure placental function may improve pregnancy outcome, compared with standard care for women at or near term (at least 36 weeks gestation); and if so to assess the feasibility of a large multicentre trial. The primary neonatal outcome was a composite measure which includes perinatal dealth, five minute Apgar score <7, umbilical artery pH <7.05 or admission to the neonatal intensive care unit for at least 48 hours. Other neonatal outcomes included small for gestational age, length of stay in hospital, duration of respiratory support and number of dependency days on the neonatal unit.
Over a period of approximately 9 months, 216 participants were recruited in total at 8 sites and follow-up of those participants has finished.
Contact: Lindsay Armstrong-Buisseret
Funding: NIHR Clinican Scientist Fellowship
Status: Reporting
Publications: 2015-38, 2018-17
Further Information: Lindsay Armstrong-Buisseret (Trial Manager) remit2@nottingham.ac.uk