Human Milk Fortifier - Growth Evaluation

Nestlé

Status: Completed

Conditions: Premature Birth

Treatments: Dietary Supplement: Human milk fortifier

Study type: Interventional

Funder types: Industry

Identifiers

NCT01771588

08.08.INF

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: Under 1 month old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 3 patient groups

New human milk fortifier

Experimental group

Description:

New human milk fortifier

Treatment:

Dietary Supplement: Human milk fortifier

Currently marketed fortifier

Active Comparator group

Description:

Currently marketed fortifier

Treatment:

Dietary Supplement: Human milk fortifier

New human milk fortifier with new Ca source

Experimental group

Description:

a subgroup of patients will receive the new milk fortifier containing a new source of calcium.

Treatment:

Dietary Supplement: Human milk fortifier