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

Feeding Patterns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824377
• Other study ID #: 22-058
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: August 2023
• Source: Cook County Health
• Contact: Aashika Janwadkar, MD
• Phone: 6469343483
• Email: aashika.janwadkar[@]cookcountyhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Methods:

The study will be a randomized control trial at our NICU (Neonatal Intensive Care Unit) (Level III). Preterm infants on non -invasive ventilation (nasal intermittent positive pressure ventilation (NIPPV)/ continuous positive airway pressure (CPAP)) will be randomly assigned into either continuous feeds or bolus feeds groups. Baby will be fed enterally through a nasogastric tube via continuous or bolus feeds using either maternal milk or formula, according to parental choice. Feeds will be advanced as per the feeding guidelines or per treating physician. Currently we use both bolus and continuous feeding practice in our NICU, as per physician's discretion.

Intervention:

Infants will be randomized into 2 groups; one will receive continuous nasogastric feeding and the other group will receive intermittent bolus feeds. Continuous feeds will be delivered via an indwelling nasogastric/orogastric tube with a continuous infusion pump. Intermittent bolus feedings will be given by gravity every 3 hours over 15- 30 minutes.

Parents' consent will be taken when the infant is qualified for the study. The consent will be taken by one of the coinvestigators. Each coinvestigator will be trained to consent for standardization. Non-English-speaking parents will be consented using the medical video interpreter (Voyce). Accent will not be obtained as neonates aren't mature to give accent.

Patients will be randomized into each group by pulling a sealed envelope.

Monitoring for complications:

During the study, infants will be monitored for any complications due to either feeding protocol like feeding intolerance, reflux, abdominal distension, poor weight gain, any risk of aspiration pneumonia or necrotizing enterocolitis (NEC). Such symptoms are usually monitored by our NICU team as per our guidelines. These feeding issues can be encountered in either group. If such problems are encountered, feeding protocol will be changed as per the physician's clinical decision. Parents will be informed of the changes. Intention to treat protocol will be used while calculating the statistical analysis.

Guidelines for withholding the feeds (bolus or intermittent) or changing either group will be:

1. Excessive gastric residual (> 50% of the volume fed)

2. Increase in abdominal girth (>1.5-2.5 cm along with other signs and symptoms of intolerance to feeds)

3. Poor/slow weight gain (rate of weight gain is significantly below that expected for age and sex, or if weight has dropped ≥2 major percentile lines)

4. Occult blood positive in stools/visible blood in the stools

5. Concerns for neonatal sepsis clinically as per attending's discretion

6. Apnea pertaining for more than 20 secs alone or apnea for > 10 seconds along with bradycardia (<80) or desaturations (hypoxemia as per gestational age); and occurring more than 2 or 3 times a day and requiring intervention

7. Abnormal Abdominal X rays concerning for suspected NEC or NEC as per Bell's criteria

8. Infants who need to be on invasive ventilation

9. Treating physician's clinical decision

Feeding protocol:

BW: 500 -1000 grams:

Initiate: When baby is stable. Start with trophic feeds, that is, 5 -10 ml/kg/day.

Advance: If tolerating trophic feeds for 2-3 days, advance feeds by 10 ml/kg/day.

Initial choice of milk: Breast Milk/Donor Breast Milk / Formula (Enfamil) - 20Kcal/Oz.

Fortify: When 60-80 ml/kg/day feeds are reached, fortify to 22Kcal/Oz and within next few days to 24 Kcal/Oz.

BW 1000 - 1500 grams:

Initiate: When baby is stable. Trophic feeds 5-10 ml/kg/day. Advance: 15-20 ml/kg/day Initial choice of milk, fortifying and full feeds as above.

BW 1500 grams and above:

Initiate: 30 ml/kg/day. Advance: 20 -35 ml/kg/day Initial choice of milk, fortifying and full feeds as above.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Feeding Patterns
• Prematurity; Extreme
• Ventilator Lung; Newborn

Intervention

Other:
• Continuous Feeds
Continuous feeds will be delivered via an indwelling nasogastric/orogastric tube with a continuous infusion pump.
• Intermittent Bolus Feeds
Intermittent bolus feedings will be given by gravity every 3 hours over 15- 30 minutes.

Locations

Country	Name	City	State
United States	Cook County Helath	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rajeev Kumar

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

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.