Effect of donor human milk on severe infections and mortality in VLBW infants, a double blind randomized controlled trial

Effect of donor human milk on severe infections and mortality in VLBW infants, a double blind randomized controlled trial - Early nutrition study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39540

Enrollment

396

Registered

2012-01-04

Start date

2012-03-30

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

infections

Interventions

If own mother*s milk is not available in sufficient amounts, the intervention group (group A) will receive additional donor milk and the placebo group (group B) will receive additional standard pret

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: birth weight

Exclusion criteria

Exclusion criteria: - Child of mother that abused drugs and/or alcohol during pregnancy - Major congenital anomalies or birth defects - Suspected congenital infection - Perinatal asphyxia with (umbilical or first neonatal) pH

Design outcomes

Primary

Measure	Time frame
- Combined incidence of serious infections/NEC and death. Amendement ESS: - Bone density as determined by DXA at term corrected age for infants from VUmc and the UMCN. Amendement Adrenocortical funtion: - Production and metabolism of cortisol at ages 10 and 30 days, in infants in VUmc. - Physiological responses (hart rate, saturation and respiratory rate) following a 35 dB stimulus (ALGO test), in infants from VUmc. Amendement Body Composition: - Body composition at corrected age of 1, 2 and 5 years measured with air displacement plethysmography (ADP) en deuterium dilusion in infants from VUmc and AMC. - Relation between the timing of introduction and the composition of complementary feeding and body composition.	—

Measure

Time frame

- Combined incidence of serious infections/NEC and death. Amendement ESS: - Bone density as determined by DXA at term corrected age for infants from VUmc and the UMCN. Amendement Adrenocortical funtion: - Production and metabolism of cortisol at ages 10 and 30 days, in infants in VUmc. - Physiological responses (hart rate, saturation and respiratory rate) following a 35 dB stimulus (ALGO test), in infants from VUmc. Amendement Body Composition: - Body composition at corrected age of 1, 2 and 5 years measured with air displacement plethysmography (ADP) en deuterium dilusion in infants from VUmc and AMC. - Relation between the timing of introduction and the composition of complementary feeding and body composition.

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Secondary

Measure	Time frame
- Composition of fecal microbiota - Time to full enteral feeding - Days on TPN - Growth rate during admission (comparable to infants fed preterm formula) and at corrected age of 2 years - Bone density comparable to infants fed preterm formula, by ultra sound (in sub group) - Cognitive, motor and language development at 2 years of corrected age (Bayley Scales of Infant Development III test, BSID III) Amendement ESS: - An improved bone mineral content (BMC) measured by SOS (ultrasound) measurement during admission and at term corrected age - An incidence of feeding intolerance comparable to infants who receive late supplementation - Earlier attainment of full enteral feeding (defined as an intake of >=150 ml/kg/day) - Improved mineral homeostasis - Reduced number of days on TPN (lipids and amino acids) - Improved growth rate until term corrected age compared late supplementation To determine whether higher amounts of parenterally administered minerals (standard regimen at the RUNMC) results in a increased BMC compared to a lower amount (standard TPN regimen at the VUmc). Amendement Adrenocortical Function: - Cortisol (in urine) at 2 years of age in infants from VUmc. Amendement Body Composition: - Relation between the timing of introduction and the composition of complementary feeding and the development of allergic diseases.	—

Measure

Time frame

- Composition of fecal microbiota - Time to full enteral feeding - Days on TPN - Growth rate during admission (comparable to infants fed preterm formula) and at corrected age of 2 years - Bone density comparable to infants fed preterm formula, by ultra sound (in sub group) - Cognitive, motor and language development at 2 years of corrected age (Bayley Scales of Infant Development III test, BSID III) Amendement ESS: - An improved bone mineral content (BMC) measured by SOS (ultrasound) measurement during admission and at term corrected age - An incidence of feeding intolerance comparable to infants who receive late supplementation - Earlier attainment of full enteral feeding (defined as an intake of >=150 ml/kg/day) - Improved mineral homeostasis - Reduced number of days on TPN (lipids and amino acids) - Improved growth rate until term corrected age compared late supplementation To determine whether higher amounts of parenterally administered minerals (standard regimen at the RUNMC) results in a increased BMC compared to a lower amount (standard TPN regimen at the VUmc). Amendement Adrenocortical Function: - Cortisol (in urine) at 2 years of age in infants from VUmc. Amendement Body Composition: - Relation between the timing of introduction and the composition of complementary feeding and the development of allergic diseases.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)