Feeding Patterns Clinical Trial
Official title:
To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.
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).
Status | Recruiting |
Enrollment | 46 |
Est. completion date | February 1, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Preterm Infants 24- 34 weeks of gestation 2. On Non-invasive ventilation (NIPPV/CPAP/HFNC) 3. Nothing by mouth (NPO) or on trophic feeds (<20 ml/kg/day) at the time of randomization. Exclusion Criteria: 1. Gestational Age > 34 weeks 2. Infants on invasive ventilation or low flow nasal cannula and on feeding volume more than trophic feeds. 3. Major congenital anomalies. |
Country | Name | City | State |
---|---|---|---|
United States | Cook County Helath | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rajeev Kumar |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Feeding interruptions | Interruptions while feeding, which includes NPO days, Lab usage and Radiological evaluation. | From the date of randomization until the date of NICU discharge/death, assessed up to 1 year. | |
Secondary | Time to reach (day of life) first oral feed | Day of life when infant was taking oral feeds (no feeds by nasogastric tube) | From the date of randomization until the date of NICU discharge/death, assessed up to 1 year. | |
Secondary | Weight gain, head circumference (HC) and Length. | Anthropometric parameters | From the date of randomization until the date of NICU discharge/death, assessed up to 1 year. | |
Secondary | Length of hospital stay | Total duration of hospital stay | From the date of randomization until the date of NICU discharge/death, assessed up to 1 year. | |
Secondary | Use of investigative medicine for feeding intolerance | Use of radiographic imaging or blood work-up to rule out any feeding intolerance | From the date of randomization until the date of NICU discharge/death, assessed up to 1 year. |
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