CompletedNot Applicable

Inclined Positioning and Infant Gastroesophageal Reflux

United States35 participantsStarted 2021-03-15

Plain-language summary

The purpose of this voluntary research study is to evaluate the extent to which infants with Gastroesophageal Reflux (GER) exhibit oxygen desaturation (low oxygen levels in their blood) and bradycardia (slow heart rate) in supine (lying flat on back) and inclined positions.

Who can participate

Age range

1 Month – 5 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * born at \>= 34 weeks gestation * weight for age \>= 10th percentile * No serious medical conditions * English-speaking parent capable of consenting * Diagnosis of GER from healthcare provider (not necessary for controls) * 4 or more visible spit-ups (mouth or nose) per day for at least 5 days OR 2 or more spit-ups out of the nose per day for at least 5 days OR I-GERQ score \>=16 (not necessary for controls) * If applicable, parent willing to refrain from giving medication for GER for 12 hours prior to study participation Exclusion Criteria: * Signs of a more serious or complex illness including weight loss, lethargy, fever, excessive irritability/pain, bulging fontanelle, seizures, macro/microcephaly, bilious vomiting, hematemesis, chronic diarrhea, rectal bleeding, suspicions of GI obstruction * History of a Brief Resolved Unexplained Event (BRUE) * Use of a Home Apnea Monitor prescribed by a healthcare provider

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of hypoxic episodes

Timeframe: 1 hour observation period

Number of bradycardia episodes

Timeframe: 1 hour observation period

Number of observed regurgitations

Timeframe: 1 hour observation periods

Trial details

NCT IDNCT04542239

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-01-25

View on ClinicalTrials.gov More Gastroesophageal Reflux trials

Who can participate

Age range

1 Month – 5 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.