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Donor milk for improved neurodevelopmental outcomes

Donor human milk versus preterm formula as a substitute for mothers' own milk for feeding very low birth weight infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35317141
Enrollment
352
Registered
2010-08-10
Start date
2010-09-14
Completion date
Unknown
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodevelopmental outcomes Neonatal Diseases Neurodevelopmental outcomes

Interventions

Treatment Group: Infants randomised to the intervention group will receive donor milk when mothers' own milk is unavailable. Infants will continue to receive donor milk after transfer

Sponsors

The Hospital for Sick Children
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Cognitive composite score on the Bayley Scales of Infant and Toddler Development-III (BSID-III) at 18 - 24 months corrected age.

Secondary

MeasureTime frame
1. Morbidity/mortality 2. Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP) 3. Growth (Secondary): 3.1. Weight (g/kg/d), length (mm/wk) and head circumference (mm/wk) gain 3.2. Weight-for-age, length-for-age and head circumference-for-age z-scores 4. Development (Secondary): 4.1. Language and motor composite scores on the BSID-III at 18-24 months corrected age 5. Feeding Tolerance and Nutrient Intake (Exploratory) 5.1. Days to full enteral feeding (150 ml/kg/d) 5.2. Days feedings withheld 5.7. Estimated energy and select nutrient intakes (protein, fat, calcium, phosphorus, iron, zinc) 6. Growth and Breastfeeding (Exploratory) 6.1. Weight-for-age, length-for-age and head circumference-for-age z-scores to 18-24 months corrected age 6.2. Duration (days) of human milk feeding (mothers? own milk) 6.3. Exclusivity of human milk feeding (mothers? own milk) at each infant?s 4, 6 and 12 months corrected age 7. Cost effectiveness (medical and non-medical) from a societal perspective (Exploratory) Added 20/09/2017: 8. Gut microbiome characterization (Exploratory

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026