Additional Protein Fortification in Extremely Low Birth Weight Infants

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.

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Key information

Conditions

Premature Birth Failure to Thrive Female Urogenital Diseases and Pregnancy Complications Growth Failure Infant, Extremely Low Birth Weight Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Severe malformations

Treatment and study plan

nutrition: protein intake

Other

additional protein fortification of human milk

Primary outcomes

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

Time frame: One and two weeks after the beginning of additional protein fortification

Sponsors and collaborators

Lead sponsor

Hôpital de la Croix-Rousse

Other

Registry information

Official study title

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

Acronym: PROTSUP

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Aug 4, 2015
Registry last updated: Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed