Additional Protein Fortification in Extremely Low Birth Weight Infants

Premature Birth Clinical Trial

— PROTSUP  

Official title:

Evaluation of Additional Protein Fortification in Extremely Low Birth Weight Infants Fed Human Milk: PROTSUP Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515266
• Other study ID #: 20121
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: July 31, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Hôpital de la Croix-Rousse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

• infants weighing <1250 g at birth

• exclusively fed with fortified HM

Exclusion Criteria:

• Severe malformations

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Other:
• nutrition: protein intake
additional protein fortification of human milk

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital de la Croix-Rousse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No