Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Human Milk in Preterm Infants

NCT05228535

Preterm Birth

UNKNOWN NA

Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet

NCT03839173

Premature Infant Breast Milk Expression

UNKNOWN NA

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

NCT04325308

Prematurity; Extreme Feeding Disorder Neonatal Breast Milk Expression +2 more

ACTIVE_NOT_RECRUITING NA

Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis

NCT06870318

Human Milk Fortification Very Low Birth Weight Baby Human Milk Nutrition +6 more

COMPLETED

Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

NCT00760942

Infant, Very Low Birth Weight

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth in Premature Infants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

liquid protein supplement

Study subjects will receive standard of care nutrition with the addition of a liquid protein supplement when the baby is able to tolerate an enteral feeding volume of 40mL/kg/day.

Group Type EXPERIMENTAL

liquid protein supplement

Intervention Type DIETARY_SUPPLEMENT

The liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth.

Control group

Study subjects will receive standard of care nutrition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

liquid protein supplement

The liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abbott liquid protein supplement

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* inborn at Mount Sinai Medical Center
* gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
* plan by family for their infant to receive human milk feeds

Exclusion Criteria

* outborn infants
* gestational age \< 26 0/7 weeks or \> 33 0/7 weeks
* major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
* sepsis and/or other serious clinical complication precluding initiation of enteral feeds
* plan by family for their infant to receive primarily preterm infant formula.

Minimum Eligible Age

26 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No