To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.

NCT05824377 | Unknown DMC

• 1 other identifier: 22-058
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).

Conditions

Prematurity; Extreme; Feeding Patterns; Ventilator Lung; Newborn

Keywords

Preterm infants; Feeding methods; bolus feeds; continuous feeds; non-invasive ventilation; RAM cannula

Outcome Measures

Primary Outcomes (1)

• Day of life to reach full feeds

  the day of life to reach full feed, that is, 120 ml/kg/day.

  From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.

Secondary Outcomes (5)

• Feeding interruptions

  From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.

• Time to reach (day of life) first oral feed

  From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.

• Weight gain, head circumference (HC) and Length.

  From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.

• Length of hospital stay

  From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.

• Use of investigative medicine for feeding intolerance

  From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.

Study Arms (2)

Bolus Feeding

EXPERIMENTAL

Intermittent bolus feeding will be defined as delivering enteral nutrition multiple times, usually every 2-3 hours over 15 - 30 minutes by gravity or an electric pump. It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, \>1500 g).

Other: Intermittent Bolus Feeds

Continuous Feeding

EXPERIMENTAL

Continuous feeding will be defined as delivering enteral nutrition with constant speed for 24 hours via a nutritional pump. It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, \>1500 g).

Other: Continuous Feeds

Interventions

Continuous Feeds OTHER

Continuous feeds will be delivered via an indwelling nasogastric/orogastric tube with a continuous infusion pump.

Continuous Feeding

Intermittent Bolus Feeds OTHER

Intermittent bolus feedings will be given by gravity every 3 hours over 15- 30 minutes.

Bolus Feeding

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm Infants 24- 34 weeks of gestation
• On Non-invasive ventilation (NIPPV/CPAP/HFNC)
• Nothing by mouth (NPO) or on trophic feeds (\<20 ml/kg/day) at the time of randomization.

You may not qualify if:

• Gestational Age \> 34 weeks
• Infants on invasive ventilation or low flow nasal cannula and on feeding volume more than trophic feeds.
• Major congenital anomalies.

Sponsors & Collaborators

• Rajeev Kumar: lead

Study Sites (1)

Cook County Helath

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (6)

• Cresi F, Maggiora E, Borgione SM, Spada E, Coscia A, Bertino E, Meneghin F, Corvaglia LT, Ventura ML, Lista G; ENTARES Study Research Group. Enteral Nutrition Tolerance And REspiratory Support (ENTARES) Study in preterm infants: study protocol for a randomized controlled trial. Trials. 2019 Jan 18;20(1):67. doi: 10.1186/s13063-018-3119-0.

  PMID: 30658676 BACKGROUND

• Wang Y, Zhu W, Luo BR. Continuous feeding versus intermittent bolus feeding for premature infants with low birth weight: a meta-analysis of randomized controlled trials. Eur J Clin Nutr. 2020 May;74(5):775-783. doi: 10.1038/s41430-019-0522-x. Epub 2019 Oct 28.

  PMID: 31659243 BACKGROUND

• Mukerji A, Abdul Wahab MG, Razak A, Rempel E, Patel W, Mondal T, Beck J. High CPAP vs. NIPPV in preterm neonates - A physiological cross-over study. J Perinatol. 2021 Jul;41(7):1690-1696. doi: 10.1038/s41372-021-01122-6. Epub 2021 Jun 5.

  PMID: 34091605 BACKGROUND

• Premji SS, Chessell L. Continuous nasogastric milk feeding versus intermittent bolus milk feeding for premature infants less than 1500 grams. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD001819. doi: 10.1002/14651858.CD001819.pub2.

  PMID: 22071802 BACKGROUND

• Dumpa V, Kamity R, Ferrara L, Akerman M, Hanna N. The effects of oral feeding while on nasal continuous positive airway pressure (NCPAP) in preterm infants. J Perinatol. 2020 Jun;40(6):909-915. doi: 10.1038/s41372-020-0632-2. Epub 2020 Feb 21.

  PMID: 32086439 BACKGROUND

• Akintorin SM, Kamat M, Pildes RS, Kling P, Andes S, Hill J, Pyati S. A prospective randomized trial of feeding methods in very low birth weight infants. Pediatrics. 1997 Oct;100(4):E4. doi: 10.1542/peds.100.4.e4.

  PMID: 9310537 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Feeding Behavior; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior, Animal; Behavior; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rajeev Kumar, MD

  Cook County Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aashika Janwadkar, MD

CONTACT

6469343483; aashika.janwadkar@cookcountyhealth.org

Rajeev Kumar, MD

CONTACT

6308652091; rkumar3@cookcountyhhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Caregivers, study personnel and nurses will not be blinded, as blinding will be hard for the treating team. Parents will not be blinded as we inform about the infant's progress and plan routinely. Statisticians will be blinded during (they will receive de-identified data).
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Infants will be randomized into 2 groups; one will receive continuous nasogastric feeding and the other group will receive intermittent bolus feeds. Each group will be stratified as per weight, thus (\<1000 g, 1000-1500 g, and \> 1500 g). It will be 1-1 randomization and will be randomized into each group by pulling a sealed envelope. Protected Health Information (PHI) will be de-identified by assigning a study code. Sample size: A sample size of at least 23 in each arm was calculated using the SAS system. A power of 80% and a mean difference of 40% decrease in the length of time to achieve full feeds; and an SD of 8.5 was considered while calculating the number of patients. The mean length of time to achieve full feeds in our NICU as per chart review was 17 +/- 8.5 days.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 21, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)