Effect of supplementary pasteurised donor human milk compared with infant formula on length of neonatal hospital stay, morbidity, breastfeeding, growth, development and health care costs in moderate and late preterm babies – a randomised controlled trial

South Australian Health and Medical Research Institute0 个研究点目标入组 2,156 人开始时间: 2024年3月20日最近更新: 2024年7月29日

适应症

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•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.

•- 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.

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