Status:
UNKNOWN
Neokare Safety and Tolerability Assessment in Neonates With GI Problems
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
University of Southampton
NeoKare Nutrition Ltd
Conditions:
NEC
Gastroschisis
Eligibility:
All Genders
Up to 44 years
Brief Summary
With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians...
Detailed Description
BACKGROUND There is an increasing body of evidence to support a causal link between ingestion of cow's milk protein (CMP) containing milks and the development of gastrointestinal disturbance in preter...
Eligibility Criteria
Inclusion
- All of the following must be met:
- Current weight greater than ≥ 1.5kg (this will reduce to current weight of ≥ 1.0kg following midpoint review if no safety concerns
- Deemed by attending clinician that fortification of breast milk is desirable either to meet nutritional requirements or optimise growth
- Exclusive maternal or donor breast milk feeding (at time of starting fortifier)
- At least one of the following diagnostic criteria:
- Any previous gastrointestinal tract surgery. This may include but is not limited:
- Surgery for NEC
- Gastroschisis
- Spontaneous Intestinal Perforation
- Intestinal Atresias and Webs
- Malrotation
- Hirschsprung's disease
- Volvulus
- Exomphalos
- Meconium Ileus/plugs
- Anorectal anomalies
- Medically treated gastrointestinal disease including but not limited to necrotising enterocolitis (based on nationally agreed case definitions), meconium ileus of prematurity (clinical diagnosis), milk curd obstruction (clinical diagnosis)
- Previously suspected intolerance of cow's milk protein-based breast milk fortifier in the absence of other gastrointestinal disease (clinical diagnosis)
- Congenital gastrointestinal anomaly (not requiring surgery)
Exclusion
- Any of the following will result in exclusion:
- Known congenital metabolic disorder
- Formula fed prior to diagnosis being made
- Bilateral grade III or IV intra-ventricular haemorrhage
- Any infant who has had gastrointestinal tract surgery and received feed other than breast milk following surgery and prior to commencing the study
- Refusal of consent, refusal for the use of pasteurised donor human milk
- The reason for these exclusion criteria is to exclude any baby in whom the primary outcome may be adversely influenced by co-existing medical morbidities
Key Trial Info
Start Date :
June 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05293353
Start Date
June 9 2022
End Date
June 1 2023
Last Update
October 28 2022
Active Locations (1)
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1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD