248 Participants Needed

Early Feeding for Very Low Birth Weight Infants

ME
IE
Overseen ByIhinosen Edgal, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Tennessee
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 'Starting feeds within 6 hours of life, Early Enteral Feeding, Early Initiation of Feeds' for very low birth weight infants?

Research shows that starting early feeding in very low birth weight infants can help them reach full feeding faster, gain weight more quickly, and reduce the risk of infections. Early feeding is also found to be safe and beneficial for growth-restricted preterm infants, leading to shorter hospital stays and better overall growth.12345

Is early feeding safe for very low birth weight infants?

Research shows that starting feeds early in very low birth weight infants is generally safe and does not increase the risk of serious conditions like necrotising enterocolitis (a severe intestinal disease) or death. Early feeding can also help these infants reach full feeding faster and improve weight gain.23567

How does early enteral feeding differ from other treatments for very low birth weight infants?

Early enteral feeding involves starting feeds within 6 hours of life, which is unique because it aims to provide nutrition sooner than traditional methods that delay feeding. This approach is designed to support growth and reduce the need for intravenous nutrition, without increasing the risk of serious conditions like necrotizing enterocolitis (NEC).2891011

What is the purpose of this trial?

Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds. ELBW infants initially remained NPO for several days before initiating trophic feeds. However, data then showed that there was no increase in mortality and morbidity if trophic feeds were initiated earlier. Then data showed that a short duration of trophic feeds did not increase mortality and morbidity when compared to a prolonged duration. More recent data showed that enteral feeding should be initiated early, preferably within 24 hours of birth, because it may promote feeding tolerance, shorten the time to reach total enteral feeding, and reduce the incidence of extrauterine growth restriction and late onset sepsis without increasing the risk of developing NEC. The management of enteral nutrition in ELBW infants is still very variable. For example, there is no consensus on the optimal time point after birth at which enteral nutrition can be started. This study evaluates the benefits of starting feeds by 6 hours of life Purpose: The primary aim of this study is to evaluate if in infants ≤ 1000g birth weight, is there a benefit initiating feeds by 6 hours of life (compared to current feeding practice data of 3 days of life) on decreasing the time to attain full feeds in the first 30 days of life. The secondary aim is to evaluate if antenatal feeding discussions would streamline feeding management post-delivery.

Research Team

ME

Mohamad Elabiad, MD

Principal Investigator

UTHSC

Eligibility Criteria

This trial is for premature infants weighing ≤ 1000g at birth. It's designed to see if starting feeds within the first 6 hours of life, compared to the standard practice of waiting up to 3 days, helps them reach full volume feeds sooner in their first month.

Inclusion Criteria

Clinical care team in agreement with patient's participation
All mothers with pregnancies with estimated fetal weight close to 1000g or less.
My infant weighs 1000 g or less.

Exclusion Criteria

Clinical progression towards imminent death
Mothers who are not in a sound mental state to be consented either to their critical condition, intubated, sedated, for example
Mothers unlikely to deliver infants ≤ 1000g
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment

Infants are randomized to early feeding or standard protocol feeding. Early feeding starts within 6 hours of life.

30 days
Continuous monitoring in NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment until hospital discharge

Up to 20 weeks

Treatment Details

Interventions

  • Starting feeds within 6 hours of life
Trial Overview The study tests two feeding protocols for extremely low birth weight (ELBW) infants: one starts feeding within 6 hours after birth and the other follows a standard protocol. The goal is to determine which method leads to quicker advancement to full volume feeds without increasing health risks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Early feeding armExperimental Treatment1 Intervention
Group II: Control armActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Tennessee

Lead Sponsor

Trials
202
Recruited
146,000+

Findings from Research

Starting enteral nutrition within 3 days for very low birth weight infants (VLBWI) leads to significantly higher milk intake and a lower rate of nosocomial infections (13.8%) compared to starting after 7 days (46.2%).
While the timing of enteral nutrition does not affect growth rates, early initiation (≤ 3 days) promotes better gastrointestinal function and reduces the duration of central venous catheterization.
[Effects of enteral nutrition starting time on digestive function and growth rate in very low birth weight infants].Yu, XY., Fan, L.[2014]
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.
Early enteral feeding in preterm infants.Kwok, TC., Dorling, J., Gale, C.[2020]
In a randomized clinical trial involving 50 growth-restricted preterm infants, those who received early enteral feeding reached full feeding significantly faster and regained birth weight more quickly compared to those who were fed later.
Early feeding was associated with a lower incidence of neonatal sepsis, reduced feeding intolerance, shorter hospital stays, and better weight gain by day 16, indicating that it is a safe and beneficial practice for these vulnerable infants.
Early Versus Delayed Enteral Feeding for Achieving Full Feeding in Preterm Growth-Restricted Infants: A Randomized Clinical Trial.Ahmed, F., Dey, SK., Shahidullah, M., et al.[2020]

References

[Effects of enteral nutrition starting time on digestive function and growth rate in very low birth weight infants]. [2014]
Early enteral feeding in preterm infants. [2020]
Early Versus Delayed Enteral Feeding for Achieving Full Feeding in Preterm Growth-Restricted Infants: A Randomized Clinical Trial. [2020]
Two-hourly versus 3-hourly feeding for very low birthweight infants: a randomised controlled trial. [2017]
Early versus delayed initiation of progressive enteral feedings for parenterally fed low birth weight or preterm infants. [2018]
Compatibility of rapid enteral feeding advances and noninvasive ventilation in preterm infants-An observational study. [2022]
Early full enteral feeding for preterm or low birth weight infants. [2022]
Early enteral feeding in very low birth weight infants. [2022]
Standardized Slow Enteral Feeding Protocol and the Incidence of Necrotizing Enterocolitis in Extremely Low Birth Weight Infants. [2022]
10.China (Republic : 1949- )pubmed.ncbi.nlm.nih.gov
Clinical experience with early enteral feeding in very-low-birth-weight infants. [2015]
Early Total Versus Gradually Advanced Enteral Nutrition in Stable Very-Low-Birth-Weight Preterm Neonates: A Randomized, Controlled Trial. [2022]
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