Enteral Nutrition for Premature Birth

(ENACT Trial)

Overseen By Ariel Salas, MD, MSPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Intrauterine growth restriction, Congenital anomalies, Terminal illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

102 Participants Needed

Trial Summary

What is the purpose of this trial?

To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Enteral Nutrition for Premature Birth?

Research shows that early and progressive enteral nutrition (feeding directly into the stomach or intestines) can help premature infants grow better by reducing weight loss after birth and helping them regain their birth weight faster. ^{1 2 3 4 5}

Is enteral nutrition safe for premature infants?

Enteral nutrition for premature infants is generally considered safe, but there is a risk of necrotizing enterocolitis (NEC), a serious intestinal disease. Studies show that early and progressive enteral feeding can be done safely in clinically stable preterm infants without increasing the risk of NEC or death, although caution is advised for high-risk infants. ^{1 6 7 8 9}

How is the treatment of Exclusive Enteral Nutrition different for premature birth?

Exclusive Enteral Nutrition for premature infants focuses on providing nutrition directly to the stomach or intestines, which can help improve growth and reduce complications like feeding intolerance. This approach is different from parenteral nutrition, which delivers nutrients through the veins, and is often used when infants cannot be fed by mouth. ^{1 4 6 10 11}

Research Team

Vivek Shukla, MD

Principal Investigator

University of Alabama at Birmingham

Ariel Salas, MD, MSPH

Principal Investigator

University of Alabama at Birmingham

Jacqueline Razzaghy, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for preterm infants born between 28 and 32 weeks of gestation. It's not suitable for babies with growth restrictions (birth weight below the 10th percentile), major birth defects, or those with terminal illnesses where life support is limited.

Inclusion Criteria

Gestational age between 28 and 32 weeks of gestation

Exclusion Criteria

I do not have major birth defects or genetic disorders.

Intrauterine growth restriction (birth weight < 10th percentile)

You have a serious illness and have decided to stop receiving treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either exclusive or progressive enteral nutrition with supplemental parenteral nutrition as needed

28 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including weight, head circumference, and length measurements

32 days

Weekly visits

Treatment Details

Interventions

• Exclusive Enteral Nutrition
• Progressive Enteral Nutrition

Trial Overview The study compares two feeding strategies in premature babies: one group will start early on exclusive enteral nutrition (feeding through the gut) minimizing parenteral nutrition (IV feeding), while another group will have a delayed progression to enteral nutrition.

Participant Groups

Group I: Exclusive Enteral Nutrition Experimental Treatment 1 Intervention

This group will receive enteral feeding volumes at a rate of 60-80 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day.

Group II: Progressive Enteral Nutrition Active Control 1 Intervention

This group will receive enteral feeding volumes at a rate of 20-30 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

A study of 293 preterm infants under 1500 g birthweight showed that implementing a rapid enteral feeding protocol led to faster achievement of full feedings and earlier weight regain without increasing the risk of feeding-related complications.

Infants in the rapid feeding group were more successfully stabilized on noninvasive ventilation and did not require mechanical ventilation, indicating that this feeding approach is safe and effective for improving clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compatibility of rapid enteral feeding advances and noninvasive ventilation in preterm infants-An observational study. Behnke, J., Estreich, V., Oehmke, F., et al.[2022]

Early enteral feeding within 48 hours after birth and progressive feeding before 4 days of life in clinically stable very preterm and very low birthweight infants is safe and does not increase the risk of necrotising enterocolitis (NEC) or mortality.

There is limited evidence for feeding practices in high-risk infants, such as those born small for gestational age, and future studies should focus on objective outcomes to reduce bias in assessing the safety and efficacy of enteral feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early enteral feeding in preterm infants. Kwok, TC., Dorling, J., Gale, C.[2020]

The guideline offers evidence-based recommendations for providing essential nutrition to critically ill neonates through enteral (EN) and parenteral (PN) methods, ensuring they receive the necessary energy and nutrients when oral feeding is not possible.

For premature and very low birth weight infants facing challenges like delayed gastric emptying and respiratory issues, PN therapy is crucial, and the guideline includes specific formulas to calculate calorie supplementation when combining PN and EN support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chinese guideline for newborn nutrition support in neonates]. [2008]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Early aggressive nutrition: parenteral amino acids and minimal enteral nutrition for extremely low birth weight ( [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Early use of supplemental parenteral nutrition in critically ill patients: results of an international multicenter observational study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Implementing feeding guidelines for NICU patients [2022]

4. Norway pubmed.ncbi.nlm.nih.gov

The enigma to achieve normal postnatal growth in preterm infants--using parenteral or enteral nutrition? [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Modification of nutrition strategy for improvement of postnatal growth in very low birth weight infants. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Fast Enteral Advancement in Preterm Infants Between 1000 and 2000 g of Birth Weight. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Compatibility of rapid enteral feeding advances and noninvasive ventilation in preterm infants-An observational study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Early Enteral Feeding for Preterm or Low Birth Weight Infants: a Systematic Review and Meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Early enteral feeding in preterm infants. [2020]

10. China pubmed.ncbi.nlm.nih.gov

[Chinese guideline for newborn nutrition support in neonates]. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

Minimal enteral nutrient requirements for intestinal growth in neonatal piglets: how much is enough? [2018]