Gastroesophageal RefluxInfant GERNCT04542239
Inclined Positioning and Infant Gastroesophageal Reflux
An observational study of Gastroesophageal Reflux, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 25 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Inclined Positioning and Infant Gastroesophageal Reflux Indicators
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.
Read the detailed description
Mothers will bring their infants to the Clinical Research Center where they will be escorted to a private room. Participants will proceed to feed their infant a typical liquid meal (i.e. breastmilk or formula). Within 15 minutes of completion of the feed, infants will be placed in the prototype infant reclining device at either 0, 10, 18, or 28 degrees of incline. Infants will spend 15 minutes at each level of incline in a randomly assigned order. During this time period that each infant is under observation the infant may be entertained/distracted/comforted with white noise, music or other forms of distraction as determined by the mother or study team. Mothers may touch/caress their infant or use a pacifier to soothe infant as needed so long as each 15 minute segment is completed. Following each 15 minute segment, a "washout" period will be used such that the next 15 minute segment will not begin for a minimum of 1 minute to a maximum of 5 minutes in duration before the next incline position is begun. This allows for a clean start and stop period for each 15 minute segment that is not impacted by either the prior position or the change to the new position. This also allows mothers or study staff to pick up and comfort the infant.
During each of the four 15 minute segments, infants will be monitored using the Masimo RAD-97 pulse oximeter with data continuously collected regarding oxygen saturation and heart rate in 2-second intervals. The oxygen saturation probe will preferably be attached to a big toe, but can be placed in alternative spots consistent with usual clinical care such that a consistent reading of heart rate and oxygen saturation are recorded. A study coordinator will complete a data collection form for each segment characterizing whether GER occurred (spit-up into mouth or outside of mouth), the number of GER episodes as well as a subjective assessment of degree crying/fussing, hiccups, back arching, and breathing difficulty. The coordinator will also have a timer to measure the duration of crying in each position. Infants will be video recorded as a backup method for symptom assessment and for qualitative assessments by the study sponsor.
- Conditions
- Gastroesophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants with GER | Infants (N=25) meeting inclusion/exclusion criteria | |
| Controls without GER | Infants (N=10) meeting inclusion/exclusion criteria, but no GER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoxic episodes
Evaluate the extent to which infants exhibit oxygen desaturation (oxygen saturation <94%) in each position
Measured: 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
Measured: 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
Measured: 1 hour observation periods
Secondary outcomes (6)
Time spent in hypoxic episodes
Minutes spent in hypoxia in each position
Measured: 1 hour observation period
Time spent in bradycardic episodes
Minutes spent in bradycardia in each position
Measured: 1 hour observation period
Time spent fussing or crying
Minutes spent fussing or crying in each position
Measured: 1 hour observation period
Observed cyanosis episodes
Number of episodes of observed cyanosis (turning blue) in each position
Measured: 1 hour observation period
Subjective assessment of crying, hiccups, back arching, and respiratory distress
Yes/no answer in each position
Measured: 1 hour observation period
Subjective maternal perception of infant comfort in each position
very comfortable, comfortable, neither comfortable nor uncomfortable, uncomfortable, very uncomfortable
Measured: 1 hour observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start15 Mar 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Iron Mountains
- Responsible party
- Principal investigator, Ian M. Paul, MD, Milton S. Hershey Medical Center
- Investigators
- Ian M Paul, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542239
- Sponsor's protocol ID
- HRP591
- Acronym
- Infant GER
- Status last verified
- Apr 2022
- First submitted
- 1 Sep 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37200720
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inclined Positioning and Infant Gastroesophageal Reflux Indicators
- ClinicalTrials.gov ID
- NCT04542239
- Acronym / sponsor ID
- Infant GER / HRP591
- Conditions
- Gastroesophageal Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Iron Mountains
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mothers will bring their infants to the Clinical Research Center where they will be escorted to a private room. Participants will proceed to feed their infant a typical liquid meal (i.e. breastmilk or formula). Within 15 minutes of completion of the feed, infants will be placed in the prototype infant reclining device at either 0, 10, 18, or 28 degrees of incline. Infants will spend 15 minutes at each level of incline in a randomly assigned order. During this time period that each infant is under observation the infant may be entertained/distracted/comforted with white noise, music or other forms of distraction as determined by the mother or study team. Mothers may touch/caress their infant or use a pacifier to soothe infant as needed so long as each 15 minute segment is completed. Following each 15 minute segment, a "washout" period will be used such that the next 15 minute segment will not begin for a minimum of 1 minute to a maximum of 5 minutes in duration before the next incline position is begun. This allows for a clean start and stop period for each 15 minute segment that is not impacted by either the prior position or the change to the new position. This also allows mothers or study staff to pick up and comfort the infant.
During each of the four 15 minute segments, infants will be monitored using the Masimo RAD-97 pulse oximeter with data continuously collected regarding oxygen saturation and heart rate in 2-second intervals. The oxygen saturation probe will preferably be attached to a big toe, but can be placed in alternative spots consistent with usual clinical care such that a consistent reading of heart rate and oxygen saturation are recorded. A study coordinator will complete a data collection form for each segment characterizing whether GER occurred (spit-up into mouth or outside of mouth), the number of GER episodes as well as a subjective assessment of degree crying/fussing, hiccups, back arching, and breathing difficulty. The coordinator will also have a timer to measure the duration of crying in each position. Infants will be video recorded as a backup method for symptom assessment and for qualitative assessments by the study sponsor.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with GER | – | –Infants (N=25) meeting inclusion/exclusion criteria |
| Controls without GER | – | –Infants (N=10) meeting inclusion/exclusion criteria, but no GER |
Who may qualify
- Ages
- 1 month to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of hypoxic episodes
Time frame: 1 hour observation period
Evaluate the extent to which infants exhibit oxygen desaturation (oxygen saturation <94%) in each position
Number of bradycardia episodes
Time frame: 1 hour observation period
Evaluate the extent to which infants exhibit bradycardia (heart rate <100 beats per minute) in each position
Number of observed regurgitations
Time frame: 1 hour observation periods
Evaluate the extent to which infants exhibit clinical signs and symptoms of post-feed regurgitation in each position
6 secondary outcomes
Time spent in hypoxic episodes
Time frame: 1 hour observation period
Time spent in bradycardic episodes
Time frame: 1 hour observation period
Time spent fussing or crying
Time frame: 1 hour observation period
Observed cyanosis episodes
Time frame: 1 hour observation period
Subjective assessment of crying, hiccups, back arching, and respiratory distress
Time frame: 1 hour observation period
Subjective maternal perception of infant comfort in each position
Time frame: 1 hour observation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 37200720Paul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Paul, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypoxic episodes (time frame: 1 hour observation period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.