Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?

Conditions

• Extra Uterine Growth Restriction
• Premature Infant Disease
• VLBW - Very Low Birth Weight Infant

Eligibility Criteria

Sex

ALL

Age

1 Minute - 6 Hours

Healthy Volunteers

Not accepted

Interventions

• Starting feeds within 6 hours of life — OTHER
  Starting feeds within 6 hours of life
• Standard feeding protocol — OTHER
  Starting feeds based on standard protocol as per primary team

Study Details

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.

Key Dates

Start date

Jun 1, 2024

Status verified

Dec 2024

Primary completion

Jun 30, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

248 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Early feeding arm
• Active Comparator: Control arm

Primary Outcome Measure

Day of life reaching full feeds [ Time Frame: From birth until day of life full feeds reached in the first 30 days of life ]

Central Contacts

• Mohamad Elabiad, MD
  901-448-4751
  [email protected]
• Ihinosen Edgal, MD
  901-448-4750
  [email protected]

Locations (1)

Find similar trials in Memphis, TN