Early Feeding for Very Low Birth Weight Infants
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants are randomized to early feeding or standard protocol feeding. Early feeding starts within 6 hours of life.
Follow-up
Participants are monitored for safety and effectiveness after treatment until hospital discharge
Treatment Details
Interventions
- Starting feeds within 6 hours of life
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Tennessee
Lead Sponsor