Additional Protein Fortification in Extremely Low Birth Weight Infants

NCT02515266 | Completed

• 1 other identifier: 20121
• Study Type: observational
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

protein; growth; head circumference

Outcome Measures

Primary Outcomes (1)

• Change from baseline body weight z-scores to 1 and 2 weeks after additional protein fortification

  One and two weeks after the beginning of additional protein fortification

Interventions

nutrition: protein intake OTHER

additional protein fortification of human milk

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants weighing \<1250 g at birth, who were exclusively fed with fortified HM and received additional proteinfortification for \>12 consecutive days.

You may qualify if:

• infants weighing \<1250 g at birth
• exclusively fed with fortified HM

You may not qualify if:

• \- Severe malformations

Sponsors & Collaborators

• Hôpital de la Croix-Rousse: lead

Related Publications (1)

• Picaud JC, Houeto N, Buffin R, Loys CM, Godbert I, Hays S. Additional Protein Fortification Is Necessary in Extremely Low-Birth-Weight Infants Fed Human Milk. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):103-5. doi: 10.1097/MPG.0000000000001142.

  PMID: 26859094 DERIVED

MeSH Terms

Conditions

Premature Birth; Failure to Thrive

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-charles PICAUD, MD, PhD

  Hospices Civils de Lyon

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of neonatology

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 4, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2015-07