ISRCTN35317141
Completed
未知
Donor human milk versus preterm formula as a substitute for mothers' own milk for feeding very low birth weight infants
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- eurodevelopmental outcomes
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 363
- Status
- Completed
- Last Updated
- 5 years ago
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
If preterm milk is not inferior to HMF as a preterm human milk fortifierHealth Condition 1: R50-R69- General symptoms and signsCTRI/2024/07/070683I
Active, not recruiting
Not Applicable
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain DevelopmentPreterm BirthBreast Milk ExpressionNutrition Disorder, InfantBrain Development AbnormalityNeurodevelopmental DisordersNCT03977259Brigham and Women's Hospital130
Completed
Not Applicable
Evaluation of Human Milk Fortifiers in Preterm InfantsInfant GrowthNCT02307760Abbott Nutrition164
Unknown
Not Applicable
Nutrition of Premature Infants With Human Breastmilk FortifierGrowth AccelerationNCT03191617NEOCOSUR160
Completed
Not Applicable
PREterM FOrmula Or Donor Breast Milk for Premature BabiesAdiposityInsulin ResistanceMetabolomic ProfilemicroRNA ProfileNCT01686477Imperial College London103