Neokare Safety and Tolerability Assessment in Neonates With GI Problems

NCT05293353 | Unknown

• 1 other identifier: CHI1109
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Days of feed intolerance

  Defined as number of days enteral feed was withheld for =\>12 hours due to concerns about nasogastric aspirate colour or volume, vomiting, abdominal distension, stoma output, stooling or vomiting, as a proportion of the total number of days on which human milk-based breast milk fortifier was included in the feed

  At 38 weeks postmenstrual age (an average of 8 weeks after initial surgery/gastrointestinal disturbance)

Secondary Outcomes (60)

• Number of adverse events per infant related to the administration of human milk-based breast milk fortifier.

  At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance)

• Mean daily Energy intake between surgery/gastrointestinal disturbance and discharge

  At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance)

• Mean daily protein intake between surgery/gastrointestinal disturbance and discharge

  At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance)

• Mean daily fat intake between surgery/gastrointestinal disturbance and discharge

  At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance)

• Mean daily carbohydrate intake between surgery/gastrointestinal disturbance and discharge

  At hospital discharge (an average of 10 weeks after initial surgery/gastrointestinal disturbance)

Study Arms (2)

Breast Milk Fortification with NeoKare

Prospective cohort, 50 infants

Other: NeoKare Breast Milk Fortifier

No Breast Milk Fortification

Retrospective, historical cohort, approx 50 infants

Interventions

NeoKare Breast Milk Fortifier OTHER

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

Breast Milk Fortification with NeoKare

Eligibility Criteria

• Age: Up to 44 Weeks
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The aim of these inclusion criteria is to select a group of babies typically requiring nutritional supplementation of breast milk but in whom there is currently a reluctance to provide cow's milk-based breastmilk fortifiers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University of Southampton: collaborator
• NeoKare Nutrition Ltd: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastroschisis; Intestinal Perforation; Intestinal Atresia; Hirschsprung Disease; Hernia, Umbilical; Intestinal Volvulus; Anorectal Malformations; Meconium Ileus; Milk Hypersensitivity; Premature Birth

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Abnormalities; Megacolon; Colonic Diseases; Infant, Newborn, Diseases; Hernia, Ventral; Intestinal Obstruction; Torsion Abnormality; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mark Johnson, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Guy

CONTACT

+442381205146; andrew.guy@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 24, 2022
• Study Start: June 9, 2022
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)