LaryngomalaciaNCT07750379
Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases
A study testing PPI, vitamin D and feeding instruction in people with Laryngomalacia, run by Minia University at 1 site in Egypt.
Trial summary
Laryngomalacia is the most common congenital laryngeal anomaly in children and is frequently associated with aspiration. This randomized controlled study aims to assess the role of proton pump inhibitor (PPI) therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Laryngomalacia
- What is being tested?
- PPI, vitamin D and feeding instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with laryngomalacia by laryngoscopic examination with a history of recurrent choking attacks or aspiration symptoms.
- Children aged from 6 months to 5 years.
Who cannot join
- Children with any neurological impairment.
- Children with other congenital anomalies.
- Children with other causes of respiratory distress
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of Medicine, Minia University
Minya, Minya Governorate
Al shimaa Abd el monem, MD, 01033487196, alshima.dakhly@mu.edu.eg
About this study
Laryngomalacia is the most common congenital laryngeal anomaly in children and is frequently associated with aspiration. This randomized controlled study aims to assess the role of proton pump inhibitor (PPI) therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either a PPI treatment group or a control group. Clinical and swallowing assessments will be performed to compare aspiration incidence and swallowing outcomes between the two groups
Read the detailed description
Laryngomalacia is the most common congenital laryngeal anomaly in infants and is frequently associated with feeding difficulties and aspiration. Gastroesophageal reflux has been suggested to contribute to symptom severity and aspiration in these patients. Although proton pump inhibitors (PPIs) are commonly prescribed, evidence regarding their effectiveness in reducing aspiration is still limited.
This randomized controlled trial aims to evaluate the role of PPI therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either an intervention group receiving PPI therapy in addition to standard care or a control group receiving standard care alone. Standard care will include vitamin D supplementation and feeding instructions for all participants. Clinical evaluation and swallowing assessment will be performed at baseline and during follow-up. The incidence of aspiration and swallowing outcomes will be compared between the two groups to determine the effectiveness of adding PPI therapy to standard management. The results of this study may provide evidence to optimize the management of pediatric laryngomalacia and reduce aspiration-related complications.
- Conditions
- Laryngomalacia
- Being tested
- PPI, vitamin D, feeding instruction
- Keywords
- laryngomalacia, aspiration, PPI, GERD, Pediatric
- Medical subject headings
- Laryngomalacia, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPIDrug
Also called Esomeprazole
Proton pump inhibitor therapy administered according to the study protocol
vitamin DDietary supplement
Vitamin D supplementation administered according to the study protocol.
feeding instructionBehavioural
Standard feeding instructions provided to caregivers according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| PPI group | Experimental | Participants receive PPI therapy in addition to vitamin D supplementation and feeding instructions. Receives: Drug: PPI; Dietary Supplement: vitamin D; Behavioral: feeding instruction |
| standard group | Active comparator | Participants receive vitamin D supplementation and feeding instructions only. Receives: Dietary Supplement: vitamin D; Behavioral: feeding instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of aspiration
comparison of the incidence of aspiration between the PPI group and the standard group
Measured: 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start28 Apr 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngomalaciaStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a parallel design to one of two groups. The intervention group will receive PPI therapy in addition to standard care (vitamin D supplementation and feeding instructions), while the control group will receive standard care alone. Outcomes will be compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al shimaa Abd el monem, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750379
- Sponsor's protocol ID
- Approval No.1714/09/2025
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 6 Aug 2026
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of Proton Pump Inhibitors in Reducing Aspiration Incidence in Pediatric Laryngomalacia Cases
- ClinicalTrials.gov ID
- NCT07750379
- Acronym / sponsor ID
- Approval No.1714/09/2025
- Conditions
- Laryngomalacia
- Keywords
- laryngomalacia, aspiration, PPI, GERD, Pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2026 (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.
Laryngomalacia is the most common congenital laryngeal anomaly in children and is frequently associated with aspiration. This randomized controlled study aims to assess the role of proton pump inhibitor (PPI) therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either a PPI treatment group or a control group. Clinical and swallowing assessments will be performed to compare aspiration incidence and swallowing outcomes between the two groups
Detailed description
Laryngomalacia is the most common congenital laryngeal anomaly in infants and is frequently associated with feeding difficulties and aspiration. Gastroesophageal reflux has been suggested to contribute to symptom severity and aspiration in these patients. Although proton pump inhibitors (PPIs) are commonly prescribed, evidence regarding their effectiveness in reducing aspiration is still limited.
This randomized controlled trial aims to evaluate the role of PPI therapy in reducing the incidence of aspiration in pediatric patients with laryngomalacia. Eligible participants will be randomly assigned to either an intervention group receiving PPI therapy in addition to standard care or a control group receiving standard care alone. Standard care will include vitamin D supplementation and feeding instructions for all participants. Clinical evaluation and swallowing assessment will be performed at baseline and during follow-up. The incidence of aspiration and swallowing outcomes will be compared between the two groups to determine the effectiveness of adding PPI therapy to standard management. The results of this study may provide evidence to optimize the management of pediatric laryngomalacia and reduce aspiration-related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a parallel design to one of two groups. The intervention group will receive PPI therapy in addition to standard care (vitamin D supplementation and feeding instructions), while the control group will receive standard care alone. Outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| PPI group | Experimental | Drug: PPI, Dietary Supplement: vitamin D, Behavioral: feeding instructionParticipants receive PPI therapy in addition to vitamin D supplementation and feeding instructions. |
| standard group | Active comparator | Dietary Supplement: vitamin D, Behavioral: feeding instructionParticipants receive vitamin D supplementation and feeding instructions only. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children diagnosed with laryngomalacia by laryngoscopic examination with a history of recurrent choking attacks or aspiration symptoms.
- Children aged from 6 months to 5 years.
Key exclusion criteria (3 listed)
- Children with any neurological impairment.
- Children with other congenital anomalies.
- Children with other causes of respiratory distress
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 |
|---|---|---|
| PPIAlso: EsomeprazoleProton pump inhibitor therapy administered according to the study protocol | Drug | PPI group |
| vitamin DVitamin D supplementation administered according to the study protocol. | Dietary supplement | PPI group, standard group |
| feeding instructionStandard feeding instructions provided to caregivers according to the study protocol. | Behavioural | PPI group, standard group |
Primary outcome
Incidence of aspiration
Time frame: 2months
comparison of the incidence of aspiration between the PPI group and the standard group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Related trials for Laryngomalacia
RecruitingObservational study
Laryngomalacia, Examinations and Quality of Life in Children Before and After Treatment With Follow-up After 1 Year
Laryngomalacia, Sleep Apnea, Obstructive
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI, vitamin D and feeding instruction in people with Laryngomalacia, run by Minia University 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 2 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of aspiration (time frame: 2months). 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 6 Aug 2026.