Human Milk Fortifier - Growth Evaluation

Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01771588

Enrollment

186

Registered

2013-01-18

Start date

2011-04-30

Completion date

2015-03-31

Last updated

2016-05-05

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

Conditions

Premature Birth

Brief summary

It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

Interventions

DIETARY_SUPPLEMENTHuman milk fortifier

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

Inclusion criteria

* Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof) * Male or female * Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h * Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d. * Written informed consent has been obtained from the legal representative(s).

Exclusion criteria

* Infants with current systemic disease * Infants with a history of systemic disease * Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery. * Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age. * Infants diagnosed with any inherent metabolic disease. * Infants diagnosed with any chromosomic disease. * Receiving any commercial formula supplementation to breast milk. * Receiving steroids at the time of enrollment. * Participation in another nutritional clinical trial that may affect outcomes of this study.

Design outcomes

Primary

Measure	Time frame
Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.	21 days

Countries

Belgium, France, Germany, Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026