Pediatric Feeding DisorderD-TAPNCT07895914
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
An observational study of Pediatric Feeding Disorder and Feeding Difficulties in Infants and Young Children, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This single-center observational study aims to evaluate the validity of the D-TAP parental questionnaire for early screening of pediatric feeding disorder (PFD) in hospitalized children aged 8 to 18 months. Read more about this study
- Who is it for?
- Ages 8 to 18 months
- Conditions the study is for
- Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2026to 6 Apr 2027
- Phase
- Observational
- 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 8 to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Hospitalized children aged 8 to 18 months, born at or after 37 weeks of gestation, receiving care at the Hautepierre site of Strasbourg University Hospitals and meeting the study eligibility criteria.
Who may be able to join
- Children aged 8 to 18 months, inclusive, receiving care within the pediatric medical-surgical department at the Hautepierre site.
- Children born at or after 37 weeks of gestation. Parents who are French-speaking.
- Parents affiliated with a social security or health insurance scheme.
- Parents who have agreed to participate in the study.
Who cannot join
- Parents who refuse participation.
- Children diagnosed with a neurodevelopmental disorder.
- Children with oromyofacial malformations.
- Children with digestive conditions affecting oral feeding, including esophageal achalasia, esophageal atresia, necrotizing enterocolitis, gastroschisis, Hirschsprung disease, eosinophilic esophagitis, omphalocele, chronic intestinal pseudo-obstruction, or short bowel syndrome.
- Children with neurological conditions affecting feeding, including pediatric stroke, spinal muscular atrophy, developmental and epileptic encephalopathies, congenital myopathies, cerebral palsy, CHARGE syndrome, congenital myasthenic syndromes, Prader-Willi syndrome, Rett syndrome, Smith-Lemli-Opitz syndrome, traumatic brain injury, or trisomy.
- Children with a history of prolonged hospitalization or invasive care during the neonatal period.
- Children currently receiving or previously having received artificial nutrition, whether enteral or parenteral.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pediatric Surgery Department, Hautepierre Hospital, University Hospital of Strasbourg, France
Strasbourg, 67091
Isabelle Talon, MD, PhD, 33 3 88 12 72 96, Isabelle.TALON@chru-strasbourg.fr
Isabelle Talon, MD, PhD
About this study
Official title: Single-Center Observational Study on the Validity of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
This single-center observational study aims to evaluate the validity of the D-TAP parental questionnaire for early screening of pediatric feeding disorder (PFD) in hospitalized children aged 8 to 18 months. Currently, no standardized screening test is routinely used by all healthcare professionals in France to identify PFD, despite its reported prevalence and potential consequences for child development, family well-being, and healthcare costs.
The D-TAP questionnaire will be compared with the Montreal Children's Hospital Feeding Scale. A blinded clinical speech-language pathology assessment of information collected during a semi-structured parental interview will be used to identify signs suggestive of PFD.
A total of 100 children will be included. The study will assess the diagnostic performance of the D-TAP questionnaire, identify an optimal screening threshold, and explore whether parents initiate contact with a community-based speech-language therapist within six weeks after being informed of signs suggestive of PFD.
- Keywords
- Pediatric Feeding Disorder, D-TAP Questionnaire, Early Screening
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Validity of the D-TAP Parental Questionnaire
Area under the receiver operating characteristic (ROC) curve calculated from D-TAP questionnaire scores, using a blinded clinical speech-language pathology assessment of the parental interview to identify signs suggestive of pediatric feeding disorder.
Measured: During the 10-month data collection period, from February 6, 2026, to April 6, 2027.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start6 Feb 2026
- Primary completion6 Feb 2027 (estimated)
- Study completion6 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Feeding DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895914
- Sponsor's protocol ID
- RC25_0125
- Acronym
- D-TAP
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Observational Study on the Validity of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
- ClinicalTrials.gov ID
- NCT07895914
- Acronym / sponsor ID
- D-TAP / RC25_0125
- Keywords
- Pediatric Feeding Disorder, D-TAP Questionnaire, Early Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 6 Feb 2027 (estimated)
- Study completion
- 6 Apr 2027 (estimated)
- First posted
- 26 Oct 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.
This single-center observational study aims to evaluate the validity of the D-TAP parental questionnaire for early screening of pediatric feeding disorder (PFD) in hospitalized children aged 8 to 18 months. Currently, no standardized screening test is routinely used by all healthcare professionals in France to identify PFD, despite its reported prevalence and potential consequences for child development, family well-being, and healthcare costs.
The D-TAP questionnaire will be compared with the Montreal Children's Hospital Feeding Scale. A blinded clinical speech-language pathology assessment of information collected during a semi-structured parental interview will be used to identify signs suggestive of PFD.
A total of 100 children will be included. The study will assess the diagnostic performance of the D-TAP questionnaire, identify an optimal screening threshold, and explore whether parents initiate contact with a community-based speech-language therapist within six weeks after being informed of signs suggestive of PFD.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospitalized children aged 8 to 18 months, born at or after 37 weeks of gestation, receiving care at the Hautepierre site of Strasbourg University Hospitals and meeting the study eligibility criteria.
Key inclusion criteria (4 listed)
- Children aged 8 to 18 months, inclusive, receiving care within the pediatric medical-surgical department at the Hautepierre site.
- Children born at or after 37 weeks of gestation. Parents who are French-speaking.
- Parents affiliated with a social security or health insurance scheme.
- Parents who have agreed to participate in the study.
Key exclusion criteria (7 listed)
- Parents who refuse participation.
- Children diagnosed with a neurodevelopmental disorder.
- Children with oromyofacial malformations.
- Children with digestive conditions affecting oral feeding, including esophageal achalasia, esophageal atresia, necrotizing enterocolitis, gastroschisis, Hirschsprung disease, eosinophilic esophagitis, omphalocele, chronic intestinal pseudo-obstruction, or short bowel syndrome.
- Children with neurological conditions affecting feeding, including pediatric stroke, spinal muscular atrophy, developmental and epileptic encephalopathies, congenital myopathies, cerebral palsy, CHARGE syndrome, congenital myasthenic syndromes, Prader-Willi syndrome, Rett syndrome, Smith-Lemli-Opitz syndrome, traumatic brain injury, or trisomy.
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
Diagnostic Validity of the D-TAP Parental Questionnaire
Time frame: During the 10-month data collection period, from February 6, 2026, to April 6, 2027.
Area under the receiver operating characteristic (ROC) curve calculated from D-TAP questionnaire scores, using a blinded clinical speech-language pathology assessment of the parental interview to identify signs suggestive of pediatric feeding disorder.
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 26 Oct 2026.
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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.
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 Pediatric Feeding Disorder and Feeding Difficulties in Infants and Young Children, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 7 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 26 Oct 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 France. 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?
Contact Isabelle Talon, MD, PhD (33 3 88 12 72 96, Isabelle.TALON@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Validity of the D-TAP Parental Questionnaire (time frame: During the 10-month data collection period, from February 6, 2026, to April 6, 2027.). 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 26 Oct 2026.