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

August 29, 2023 updated by: Rajeev Kumar
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Cook County Helath
        • Contact:
          • Rajeev Kumar, MD
        • Sub-Investigator:
          • Aashika Janwadkar, MD
        • Sub-Investigator:
          • Aarti Kulkarni, MD
        • Sub-Investigator:
          • Nita Shrestha, MD
        • Principal Investigator:
          • Rajeev Kumar, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bolus Feeding

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Day of life to reach full feeds
Time Frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding interruptions
Time Frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
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.
Time to reach (day of life) first oral feed
Time Frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
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.
Weight gain, head circumference (HC) and Length.
Time Frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Anthropometric parameters
From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Length of hospital stay
Time Frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
Total duration 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
Time Frame: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajeev Kumar

Investigators

  • Principal Investigator: Rajeev Kumar, MD, Cook County Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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