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Additional Protein Fortification in Extremely Low Birth Weight Infants

NCT02515266 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2015-08-04

No results posted yet for this study

Summary

Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit.

The quantitative objective is to achieve growth that is at least equivalent to that of the fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). Children often grow during difficult 10-15 first days of life, so they accumulate a delay that should compensate them secondarily. Therefore, optimum postnatal growth is rather 20 g/kg.day than 15 g/kg.day.

Individualized fortification of human milk (HM) has been proposed to optimize postnatal growth. Specifically, the lack of protein intake is responsible for sub-optimal postnatal growth in preterm infants.

The objectives of this study are to determine the effectiveness of additional protein fortification (APF) in terms of short-term growth along with the proportion of extremely low birth weight (ELBW) infants requiring APF.

Conditions

  • Premature Birth
  • Infant, Extremely Low Birth Weight
  • Growth Failure

Interventions

OTHER

nutrition: protein intake

additional protein fortification of human milk

Sponsors & Collaborators

  • Hôpital de la Croix-Rousse

    lead OTHER

Principal Investigators

  • Jean-charles PICAUD, MD, PhD · Hospices Civils de Lyon

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515266 on ClinicalTrials.gov