Giving Donor Milk Instead of Formula in Moderate-Late Preterm Infants: the GIFT trial

Not Applicable

Recruiting

• Conditions: Feeding intolerance; Reproductive Health and Childbirth - Complications of newborn; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Reproductive Health and Childbirth - Breast feeding

• Registration Number: ACTRN12624000289516
• Lead Sponsor: South Australian Health and Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-20
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2156

Inclusion Criteria

32+0 and 36+6 completed weeks’ gestation at birth;*
- Birth weight >= 1500g;
- Admitted to the neonatal unit;**
- Clinically stable as determined by the treating physician;
- Ready to commence enteral feeds or commenced enteral feeds with human milk but insufficient maternal breast milk is available as decided by the treating health care team;
- Aged <= 96 hours;
- Has a parent or guardian who is at least 16 years of age and is capable of giving informed consent.

*Only infants with a gestation of >=34 weeks at birth will be enrolled at the Royal Brisbane and Women’s Hospital, this is consistent with the process undertaken in our pilot study.

**If it is anticipated that an infant will be transferred to the postnatal ward or another hospital quickly (e.g. within 8 hours) then they will not be eligible for the study, as for practical reasons the study nutrition will not be able to be administered on the postnatal ward or to non-participating hospitals.

Exclusion Criteria

- Documented, suspected or confirmed metabolic disorder that precludes breastfeeding;
- Major congenital malformation either likely to interfere with the ability to ingest milk or requiring surgery in the first 6 months of life ((including abnormalities of the central nervous system, cardiovascular system, urinary system, gastrointestinal system, chromosomal, metabolic, musculoskeletal, respiratory, diaphragmatic hernia, haematological, tumours or any other unspecified major abnormality);
- Has been given infant formula prior to randomisation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength of neonatal hospital stay (days)[Assessed by data collected from medical records at each site to find the difference between the date of hospital discharge and date of birth At discharge from hospital ]