Gastroesophageal Reflux in NeonatesPhase 4NCT04788485
Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
A Phase 4 study testing Diosmectite in people with Gastroesophageal Reflux in Neonates, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment Read more about this study
- Who is it for?
- Ages 0 to 30 days
- Conditions the study is for
- Gastroesophageal Reflux in Neonates
- What is being tested?
- Diosmectite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Mar 2021
- Phase
- Phase 4
- 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 0 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Newborns free of any congenital anomalies or inborn errors of metabolism
- Infants had signs of reflux like:
- Typical or atypical crying and/or irritability
- Apparent life-threatening event
- Poor appetite; weight loss or poor growth (failure to thrive)
- Vomiting
Show all 10Show fewer
- Bronchopulmonary dysplasia
- Wheezing, stridor
- Recurrent pneumonitis
- Sandifer syndrome (ie, posturing with opisthotonus or torticollis)
Who cannot join
- • Newborns with GIT anomalies as trans-esophageal fistula, hiatus hernia and other GIT anomalies causing reflux.
- Patients with Hirshsprung disease or delayed passage of meconium.
- History of NEC in the baby.
Trial locations and contacts
1 site in 1 country.
About this study
study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment
Read the detailed description
This is a prospective clinical trial conducted on 20 preterm neonates < 37 weeks of gestation, admitted in NICU, maternity hospital, Ain Shams University. They were assessed for gastroesophageal reflux disease and investigated using ph-MII for detection of reflux episodes and they were given Smecta 3gm/day for 7 days at least as a food thickener and then ph-MII repeated to assess the response
- Conditions
- Gastroesophageal Reflux in Neonates
- Being tested
- Diosmectite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiosmectiteDrug
Also called Smecta
use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates
| Study group | Role | What they receive |
|---|---|---|
| Neonates before adding smectite | Active comparator | neonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph Receives: Drug: Diosmectite |
| neonates after adding smectite | Active comparator | neonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph Receives: Drug: Diosmectite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates
efficacy of Smectite as a food thickener in treating GERD in neonates using Multichannel intraluminal impedance-pH monitoring.
Measured: within 7 days
Secondary outcomes (1)
Reliability of signs for diagnosis of gastroesophageal reflux in neonates using MII-pH
determine the reliability of signs such as cardio-respiratory events, apneas and dystonic neck posturing (Sandifer syndrome) in the diagnosis of GERD using Multichannel intraluminal impedance-pH monitoring.
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Sep 2017
- Primary completion25 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux in NeonatesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Fayez Ahmed, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788485
- Sponsor's protocol ID
- PH-MII in neonates
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
- ClinicalTrials.gov ID
- NCT04788485
- Acronym / sponsor ID
- PH-MII in neonates
- Conditions
- Gastroesophageal Reflux in Neonates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 9 Mar 2021 (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.
study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment
Detailed description
This is a prospective clinical trial conducted on 20 preterm neonates < 37 weeks of gestation, admitted in NICU, maternity hospital, Ain Shams University. They were assessed for gastroesophageal reflux disease and investigated using ph-MII for detection of reflux episodes and they were given Smecta 3gm/day for 7 days at least as a food thickener and then ph-MII repeated to assess the response
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neonates before adding smectite | Active comparator | Drug: Diosmectiteneonates will receive diosmectite for treating of gastroesophageal reflux in neonates after MII-ph |
| neonates after adding smectite | Active comparator | Drug: Diosmectiteneonates after they received diosmectite for treating of gastroesophageal reflux in neonates after MII-ph |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- • Newborns free of any congenital anomalies or inborn errors of metabolism
Key exclusion criteria (3 listed)
- • Newborns with GIT anomalies as trans-esophageal fistula, hiatus hernia and other GIT anomalies causing reflux.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiosmectiteAlso: Smectause of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates | Drug | Neonates before adding smectite, neonates after adding smectite |
Primary outcome
Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates
Time frame: within 7 days
efficacy of Smectite as a food thickener in treating GERD in neonates using Multichannel intraluminal impedance-pH monitoring.
1 secondary outcome
Reliability of signs for diagnosis of gastroesophageal reflux in neonates using MII-pH
Time frame: within 24 hours
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 11 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diosmectite in people with Gastroesophageal Reflux in Neonates, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 10 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 11 Mar 2021. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates (time frame: within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2021.