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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: Newborn
Healthy Volunteers: f
View:

• All infants less than or equal to 1000 g

• Clinical care team in agreement with patient's participation

• All mothers with pregnancies with EFW close to 1000g or less.

Locations
United States
Tennessee
Regional One Health
RECRUITING
Memphis
Contact Information
Primary
Mohamad Elabiad, MD
Melabiad@uthsc.edu
901-448-4751
Backup
Ihinosen Edgal, MD
iedgal@uthsc.edu
901-448-4750
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 248
Treatments
Experimental: Early feeding arm
Active_comparator: Control arm
Related Therapeutic Areas
Sponsors
Leads: University of Tennessee

This content was sourced from clinicaltrials.gov