Human Milk Fortifier - Growth Evaluation

N

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

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

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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