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

NCT06731439 | Recruiting

• 1 other identifier: 24-09828-FB
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Day of life reaching full feeds

  The primary outcome is the age in days in the first 30 days of life when the infant reaches full feeds.

  From birth until day of life full feeds reached in the first 30 days of life

Secondary Outcomes (11)

• Secondary Outcomes

  From birth until hospital discharge

• Secondary Outcomes

  From birth until hospital discharge

• Secondary Outcomes

  From birth until 30 days of life

• Secondary Outcomes

  From birth until hospital discharge

• Secondary Outcomes

  From birth until hospital discharge

Study Arms (2)

Early feeding arm

EXPERIMENTAL

Other: Starting feeds within 6 hours of life

Control arm

ACTIVE COMPARATOR

Other: Standard feeding protocol

Interventions

Starting feeds within 6 hours of life OTHER

Starting feeds within 6 hours of life

Early feeding arm

Standard feeding protocol OTHER

Starting feeds based on standard protocol as per primary team

Control arm

Eligibility Criteria

• Age: 1 Minute - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• congenital malformations that may affect gastro intestinal perfusion
• Clinically progressing towards imminent death
• congenital gastrointestinal obstructions
• Mothers unlikely to deliver infants ≤ 1000g
• Mothers who are not in a sound mental state to be consented either to their critical condition, intubated, sedated, for examples
• Mothers who are critically ill where by it is felt that mom will not be able to participate in the consent

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Regional One Health

Memphis, Tennessee, 38163, United States

RECRUITING

Related Publications (4)

• Parker LA, Desorcy-Scherer K, Magalhaes M. Feeding Strategies in Preterm Very Low Birth-Weight Infants: State-of-the-Science Review. Adv Neonatal Care. 2021 Dec 1;21(6):493-502. doi: 10.1097/ANC.0000000000000849.

  PMID: 33675303 BACKGROUND

• Walsh V, Brown JVE, Copperthwaite BR, Oddie SJ, McGuire W. Early full enteral feeding for preterm or low birth weight infants. Cochrane Database Syst Rev. 2020 Dec 27;12(12):CD013542. doi: 10.1002/14651858.CD013542.pub2.

  PMID: 33368149 BACKGROUND

• Morgan J, Bombell S, McGuire W. Early trophic feeding versus enteral fasting for very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD000504. doi: 10.1002/14651858.CD000504.pub4.

  PMID: 23543508 BACKGROUND

• Gao L, Shen W, Wu F, Mao J, Liu L, Chang YM, Zhang R, Ye XZ, Qiu YP, Ma L, Cheng R, Wu H, Chen DM, Chen L, Xu P, Mei H, Wang SN, Xu FL, Ju R, Zheng Z, Lin XZ, Tong XM; Chinese Multicenter EUGR Collaborative Group. Effect of early initiation of enteral nutrition on short-term clinical outcomes of very premature infants: A national multicenter cohort study in China. Nutrition. 2023 Mar;107:111912. doi: 10.1016/j.nut.2022.111912. Epub 2022 Nov 12.

  PMID: 36577163 BACKGROUND

Study Officials

• Mohamad Elabiad, MD

  UTHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamad Elabiad, MD

CONTACT

901-448-4751; Melabiad@uthsc.edu

Ihinosen Edgal, MD

CONTACT

901-448-4750; iedgal@uthsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: December 12, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)