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Postpyloric vs Gastric Feedings for Bronchopulmonary Dysplasia

N/A

Recruiting

Led By Jonathan Levin, MD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Remain on either invasive ventilation or non-invasive ventilation (continuous positive airway pressure or nasal intermittent positive pressure ventilation) for minimum 48 hours at the time of study entry. The minimum support required for inclusion is CPAP > 5cm H2O or CPAP 5 with FiO2 > 21%

Have ongoing need for respiratory support due to underlying lung disease from prematurity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over a 15 day period during study participation

Awards & highlights

Study Summary

This trial will examine which type of feeding helps preterm babies with lung problems: NG or postpyloric. It will look at both clinical outcomes & biomarkers.

Who is the study for?

This trial is for preterm infants born before 32 weeks who are between 34-44 weeks post-menstrual age, need respiratory support due to lung disease from prematurity, and can handle over 80 ml/kg/day of feedings through a tube. Infants with significant other illnesses or malformations affecting the lungs or digestion, recent serious gut issues, or temporary breathing support for reasons other than lung disease aren't eligible.Check my eligibility

What is being tested?

The study compares two ways of feeding preterm infants with chronic lung disease: traditional nasogastric (NG) feeds versus jejunal (NJ) feeds placed past the stomach. It aims to see if NJ feedings improve lung health better than NG feedings using a crossover design where each infant receives both treatments in sequence.See study design

What are the potential side effects?

Potential side effects may include discomfort at the tube insertion site, digestive problems like bloating or diarrhea, and possible irritation of the airway or lungs related to how the feeding tubes are placed and managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a ventilator or CPAP for at least 48 hours.

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I need help breathing due to lung problems from being born early.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over a 15 day period during study participation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over a 15 day period during study participation

This trial's timeline: 3 weeks for screening, Varies for treatment, and over a 15 day period during study participation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in modified respiratory severity score (mRSS)

Tracheal Aspirates

Secondary outcome measures

Nutritional Status Over the Course of the Study

Respiratory Support Over the Course of the Study

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: Jejunal Followed by Gastric FeedsExperimental Treatment2 Interventions

Participants randomized into this group will begin with one ten-day block of nasojejunal (NJ, postpyloric) feeds followed by one ten-day block of nasogastric (NG) feeds.

Group II: Group A: Gastric Followed by Jejunal FeedsExperimental Treatment2 Interventions

Participants randomized into this group will begin with one ten-day block of nasogastric (NG) feeds followed by one ten-day block of nasojejunal (NJ, postpyloric) feeds.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,880 Total Patients Enrolled

3 Trials studying Bronchopulmonary Dysplasia

290 Patients Enrolled for Bronchopulmonary Dysplasia

Beth Israel Deaconess Medical CenterOTHER

837 Previous Clinical Trials

13,010,222 Total Patients Enrolled

2 Trials studying Bronchopulmonary Dysplasia

50 Patients Enrolled for Bronchopulmonary Dysplasia

Jonathan Levin, MDPrincipal InvestigatorBoston Children's Hospital

1 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Bronchopulmonary Dysplasia

50 Patients Enrolled for Bronchopulmonary Dysplasia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age threshold for individuals to be considered eligible for the trial?

"This trial's inclusion criteria mandates that participants be between 0 hours old and 1 year of age."

Answered by AI

Am I eligible to register for the research trial?

"To become eligible for this trial, candidates should suffer from bronchopulmonary dysplasia and be between the tender ages of birth to 12 months. Approximately 50 individuals will need to join the research study."

Answered by AI

Are participants being accepted for this research endeavor at present?

"The clinical trial data hosted on the website indicates that, as of now, this medical study is not actively recruiting patients. Although the trial was first uploaded to the site on October 1st 2023 and edited lastly on October 9th 2023 - 55 other trials are presently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants

Jonathan Levin 2024. "Randomized Controlled Crossover Trial of Postpyloric Feedings to Improve Pulmonary Outcomes in High-risk Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05777512.