Neokare Safety and Tolerability Assessment in Neonates With GI Problems

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 avoid the use of CMP containing feed in high risk babies.

Delivery of adequate nutritional intake is one of the great challenges in the care of newborn infants, particularly those born preterm or with gastrointestinal problems. Whilst there are recognised benefits of human milk, a diet of exclusive human milk may not meet the nutritional demands of the infant. To close this gap, breast milk fortifier (BMF) is typically added to human milk. However, addition of BMF may be associated with gastrointestinal disturbance, possibly due to the fact that it contains CMP.

This research study is to test the tolerability and safety of a new human milk-based BMF in neonates with gastrointestinal problems. It is hoped that this may provide an opportunity for high risk infants, to receive the benefits of human milk whilst minimising the risks reported to be associated with CMP.

Eligible infants will be those in whom nutritional supplementation of breast is deemed clinically necessary, a weight of greater than 1.0kg at the time of starting fortifier and at least one of:

* previous gastrointestinal surgery
* congenital gastrointestinal anomaly
* medically treated gastrointestinal disease
* previously suspected intolerance of CMP based breast milk fortifier in the absence of other gastrointestinal disease

Infants will be started on human milk-based BMF once they are tolerating 100 mls per kilo per day of human breast milk. The human milk-based fortifier will be commenced at half the recommended dose for 48 hours then increase to full strength. This will be continued until the infant reaches 44 weeks corrected gestational age, or until such time as they are deemed to no longer require the additional nutrition.

Conditions

• NEC
• Gastroschisis
• Intestinal Perforation
• Atresia, Intestinal
• Hirschsprung Disease
• Exomphalos
• Volvulus
• Anorectal Malformations
• Meconium Ileus
• Cows Milk Allergy
• Preterm

Interventions

OTHER

NeoKare Breast Milk Fortifier

Powdered product made from human breast milk used to increase nutritional content of mother's own breast milk

Sponsors & Collaborators

• University of Southampton

  collaborator OTHER

• NeoKare Nutrition Ltd

  collaborator UNKNOWN

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Principal Investigators

• Mark Johnson, PhD · University Hospital Southampton NHS Foundation Trust

Eligibility

Max Age

44 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-09

Primary Completion

2023-04-30

Completion

2023-06-30

Countries

• United Kingdom

Study Locations