RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06731439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Minute to 6 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. All infants less than or equal to 1000 g
  2. 2. Clinical care team in agreement with patient's participation
  3. 3. All mothers with pregnancies with EFW close to 1000g or less.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mohamad Elabiad, MD
CONTACT
901-448-4751
Melabiad@uthsc.edu
Ihinosen Edgal, MD
CONTACT
901-448-4750
iedgal@uthsc.edu

Principal Investigator

Mohamad Elabiad, MD
PRINCIPAL_INVESTIGATOR
UTHSC

Study Locations (Sites)

Regional One Health
Memphis, Tennessee, 38163
United States

Collaborators and Investigators

Sponsor: University of Tennessee

  • Mohamad Elabiad, MD, PRINCIPAL_INVESTIGATOR, UTHSC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

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