What is the mechanism of action of this treatment?

Common treatments for premature infants, such as early protein supplementation and probiotics, aim to address critical developmental needs. Early protein supplementation, often through fortification of human milk, provides essential nutrients that support growth and improve fat-free mass (FFM)-for-age z scores, which are crucial for overall development and long-term health. Probiotics help in establishing a healthy gut microbiome, which is vital for digestion, nutrient absorption, and immune function. These treatments are particularly important for premature infants as they are at higher risk for growth deficiencies, infections, and gastrointestinal issues due to their underdeveloped organs and immune systems.

What side effects are associated with this type of intervention?

Common treatments for premature infants, such as early protein supplementation and fortification, generally aim to improve growth and gut health. However, these interventions can have side effects. Early fortification may lead to feeding intolerance, gastrointestinal disturbances, and metabolic imbalances. Probiotics, often used to enhance gut microbiome diversity, can occasionally cause mild gastrointestinal symptoms like bloating and gas. In rare cases, there is a risk of sepsis, particularly in immunocompromised infants. It is crucial to monitor these infants closely to manage and mitigate potential adverse effects.

What prior FDA approvals exist?

FDA approvals for the treatment of premature infants have included various nutritional interventions aimed at improving growth and health outcomes. One such intervention is the use of human milk fortifiers, which are added to breast milk to provide additional protein, calories, and essential nutrients. These fortifiers are designed to support the growth and development of very preterm infants. Additionally, specialized preterm infant formulas have been approved to meet the unique nutritional needs of these infants. These formulas often contain higher levels of protein and other nutrients to promote better growth and development, similar to the goals of early protein supplementation and fortification being studied in clinical trials.

What other types of research exist?

Promising novel alternatives to early protein supplementation for premature infants include synbiotics (a combination of probiotics and prebiotics) and prebiotics alone. These interventions have shown potential in enhancing neuronal and immunological development, as well as reducing the incidence of necrotizing enterocolitis (NEC).

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Dietary Supplement

Early Human Milk Fortification for Premature Infants (ENACT+ Trial)

N/A

Waitlist Available

Led By Ariel A. Salas, MD, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postnatal day 14 to 21

Awards & highlights

Summary

This trial is testing if giving extra protein to very preterm infants helps with their growth and gut health. The goal is to see if protein supplementation leads to better growth and a more diverse gut microbiome.

Who is the study for?

This trial is for very preterm infants with a birth weight under 1800 grams and aged less than 96 hours, born between 29 to 33 weeks of gestation. It's not suitable for babies small for their gestational age, those with terminal illnesses where support is limited, or major congenital/chromosomal anomalies.

What is being tested?

The study tests if giving very preterm infants protein supplements early (between day 4-7) versus later (day 10-14) affects their body composition and gut bacteria diversity. The trial randomly assigns infants to one of the two groups.

What are the potential side effects?

Potential side effects are not explicitly listed but may include feeding intolerance or reactions related to the timing and introduction of human milk fortification in these vulnerable infants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postnatal day 14 to 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postnatal day 14 to 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and postnatal day 14 to 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fat-free mass(FFM)-for-age Z-score

Secondary study objectives

Death

Duration of hospital stay in days

Fecal microbiome composition

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early human milk fortification (HMF) groupExperimental Treatment1 Intervention

A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved.

Group II: Delayed human milk fortification (HMF) groupActive Control1 Intervention

A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for premature infants, such as early protein supplementation and probiotics, aim to address critical developmental needs. Early protein supplementation, often through fortification of human milk, provides essential nutrients that support growth and improve fat-free mass (FFM)-for-age z scores, which are crucial for overall development and long-term health. Probiotics help in establishing a healthy gut microbiome, which is vital for digestion, nutrient absorption, and immune function. These treatments are particularly important for premature infants as they are at higher risk for growth deficiencies, infections, and gastrointestinal issues due to their underdeveloped organs and immune systems.

Enteral lactoferrin supplementation for prevention of sepsis and necrotizing enterocolitis in preterm infants.Association between duration of intravenous antibiotic administration and early-life microbiota development in late-preterm infants.Benefits of probiotics in preterm neonates in low-income and medium-income countries: a systematic review of randomised controlled trials.

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,621 Previous Clinical Trials

2,290,898 Total Patients Enrolled

Mead Johnson NutritionIndustry Sponsor

79 Previous Clinical Trials

15,941 Total Patients Enrolled

Ariel A. Salas, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham

5 Previous Clinical Trials

652 Total Patients Enrolled

Media Library

Delayed HMF (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05525585 — N/A

Premature Infants Research Study Groups: Early human milk fortification (HMF) group, Delayed human milk fortification (HMF) group

Premature Infants Clinical Trial 2023: Delayed HMF Highlights & Side Effects. Trial Name: NCT05525585 — N/A

Delayed HMF (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525585 — N/A

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