ISRCTN35317141Completed未知
Donor human milk versus preterm formula as a substitute for mothers' own milk for feeding very low birth weight infants
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 363
Study Overview
Brief Summary
- 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24884424 2. 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27825008 3. 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29546315 4. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31536118 (added 20/09/2019) 5. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31599955 (added 11/10/2019) 6. 2020 follow up results in https://pubmed.ncbi.nlm.nih.gov/31599955/ (added 10/08/2020)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Day 1 to 4 of life
- •2. Less than 1500 g birth weight
- •3. Enteral feeding is expected to be initiated in the first 7 days of life
Exclusion Criteria
- •1. Infants with serious congenital or chromosomal anomalies that may contribute to serious developmental outcome
- •2. Asphyxia (hypoxia or ischaemia) as defined by all of:
- •2.1. Severe metabolic or mixed acidaemia (pH less than 7.00 or base deficit less than -16) on an umbilical cord arterial blood sample or neonatal blood gas within first hour of life
- •2.2. Apgar score of 0 - 3 for greater than 5 minutes
- •2.3. Multi-organ system dysfunction within 72 hours of birth
- •3. Enrolment in any other clinical study affecting nutritional management during the feeding intervention
- •4. Reasonable potential that the infant will be transferred to a Neonatal Intensive Care Unit (NICU) or Level II NICU where the study protocol will not be continued
Investigators
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