Additional Protein Fortification in Extremely Low Birth Weight Infants

NCT ID: NCT02515266

Last Updated: 2015-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

In a retrospective, single-center study, premature infants weighing <1250 g at birth hospitalized in investigators' neonatal intensive care unit in 2012, who were exclusively fed with fortified HM and received APF for >12 consecutive days were included.

Weight gain (g/kg•d) over the previous 7 days was calculated daily based on weight data in patients' electronic medical records. When weight gain was considered insufficient (i.e., below 20 g/kg•d) and the serum urea level was <3 mmol/L, 1 g/kg•d protein was added. Before using the mixture, investigators verified that the osmolality was only slightly increased (from 412 to 422 mOsm/kg).

Growth and digestive tolerance were compared between the week before (Wk0) and 1 and 2 weeks after (Wk1 and Wk2, respectively) the introduction of protein supplement; each participant served as his own control. Change from baseline for body weight was the main outcome. Energy and protein intake during Wk0, Wk1, and Wk2 were calculated. Standard deviation z-scores for growth parameters were calculated 7 days before, at time of protein introduction, and 7 and 14 days after . Changes in Z-scores were calculated. The digestive tolerance score and metabolic tolerance (serum urea) were assessed during Wk0, Wk1, and Wk2 (5).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

nutrition: protein intake

additional protein fortification of human milk

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Severe malformations

• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital de la Croix-Rousse

OTHER

Sponsor Role: lead

Responsible Party

Jean-charles PICAUD, MD, PhD

Head of department of neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-charles PICAUD, MD, PhD

Role: STUDY_DIRECTOR

Hospices Civils de Lyon

References

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.

Reference Type: DERIVED

PMID: 26859094 (View on PubMed)

Other Identifiers

20121

Identifier Type: -

Identifier Source: org_study_id