Probiotics after Discharge (PAD) study
Research type
Research Study
Full title
Probiotics after discharge (PAD) Study:Impact on microbiome, health and growth outcomes
IRAS ID
196724
Contact name
Janet Berrington
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
4626, Caldicott Approval
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Probiotics (Healthy Bacteria) are used as part of routine care for infants born before 32 weeks gestation as they have been shown to reduce the incidence of Necrotizing Enterocolitis (a serious bowel condition which mainly effects preterm infants). These are started when a baby starts milk feeds and generally continued until they reach about 34 weeks of gestation. This study aims to see the effect of continuing probiotics after 34 weeks gestation on the babies gut bacteria flora (microbiome) growth and health outcomes including crying/fussing behaviours (suggesting colic). We will follow 40 infants born before 32 weeks gestation who have already taken part in our well established gut flora microbiome study during their NICU stay. We will randomise infants to either continue probiotics beyond 34 weeks corrected gestation or stop at 34 weeks (current routine practice) although parents can receive their preferred option if they wish. We will obtain stool samples at around 34 weeks gestation and then around every 6 weeks until after weaning, and again at a year.We will obtain a matched parental stool sample at either the first or second time point. We will use a parent questionnaire at the sampling points to record growth (weight, length and head circumference), health (GP or hospital visit, antibiotic use) and also assess daily crying time/colic, parents’ perceptions of colic severity using a tested visual scale. We will analyse whether receipt of probiotics affects any of these outcome measures.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0185
Date of REC Opinion
2 Aug 2016
REC opinion
Further Information Favourable Opinion