NCT04542239

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

September 1, 2020

Last Update Submit

April 27, 2022

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (3)

  • Number of hypoxic episodes

    Evaluate the extent to which infants exhibit oxygen desaturation (oxygen saturation \<94%) in each position

    1 hour observation period

  • Number of bradycardia episodes

    Evaluate the extent to which infants exhibit bradycardia (heart rate \<100 beats per minute) in each position

    1 hour observation period

  • Number of observed regurgitations

    Evaluate the extent to which infants exhibit clinical signs and symptoms of post-feed regurgitation in each position

    1 hour observation periods

Secondary Outcomes (6)

  • Time spent in hypoxic episodes

    1 hour observation period

  • Time spent in bradycardic episodes

    1 hour observation period

  • Time spent fussing or crying

    1 hour observation period

  • Observed cyanosis episodes

    1 hour observation period

  • Subjective assessment of crying, hiccups, back arching, and respiratory distress

    1 hour observation period

  • +1 more secondary outcomes

Study Arms (2)

Infants with GER

Infants (N=25) meeting inclusion/exclusion criteria

Controls without GER

Infants (N=10) meeting inclusion/exclusion criteria, but no GER

Eligibility Criteria

Age1 Month - 5 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participants will be identified through providers in the Divisions of Academic General Pediatrics, Hospital Pediatrics, and Pediatric Gastroenterology. The Department of Family and Community Medicine may also refer participants to the study.

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Paul IM, Shedlock KE, Schaefer EW, Stoute EJ, Rosen R. Pilot Study of Inclined Position and Infant Gastroesophageal Reflux Indicators. JPGN Rep. 2023 Apr 24;4(2):e312. doi: 10.1097/PG9.0000000000000312. eCollection 2023 May.

    PMID: 37200720DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ian M Paul, MD

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 9, 2020

Study Start

March 15, 2021

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

US(1)