Infant, Premature, DiseasesNCT00062452
Esophageal Motility and Airway Defenses Among Infants
An observational study of Infant, Premature, Diseases and Congenital Abnormalities, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function. Read more about this study
- Who is it for?
- Ages 2 weeks to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Diseases, Congenital Abnormalities, Perinatal Asphyxia
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Jul 2005
- 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 2 weeks to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature infants congenital foregut anomalies Perinatal asphyxia
Who may be able to join
- Prematurely born infants, Infants with congenital foregut anomalies, Infants with perinatal asphyxia, Ability to maintain vital signs at study,
Who cannot join
- No contraindication to enteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function. Prematurity, congenital anomalies and perinatal depression represent three important conditions in infants, that may have feeding and airway difficulties.Development of motility of the foregut and the adaptation during normal and disease in developing infants is unclear.
Read the detailed description
With the aid of small clinical research funding from the NIDDK, in this proposal, we have developed methods to safely evaluate foregut motility in relation to breathing among high risk infants. We are using simultaneous esophageal motility studies, swallowing and respiratory measurements in this evaluation.
- Keywords
- Esophageal, Airway
- Medical subject headings
- Infant, Premature, Diseases, Congenital Abnormalities
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 |
|---|---|---|
| A-1,2,3 | The cohort (A) comprised of high risk infants. There were 3 sub groups studied within this cohort: (1) premature infants, (2) Infants with congenital gut anomalies, and (3) perinatal asphyxia. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startMay 2002
- Primary completionApr 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Children's National Research Institute
- Responsible party
- Sponsor
- Investigators
- Sudarshan R Jadcherla, MD, Principal investigator, Nationwide Children's Hospital/The Ohio State University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062452
- Sponsor's protocol ID
- EMADAI (completed)
- Other IDs
- R03DK061502
- Status last verified
- Jan 2010
- First submitted
- 5 Jun 2003
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jadcherla SR, Duong HQ, Hoffmann RG, Shaker R. Esophageal body and upper esophageal sphincter motor responses to esophageal provocation during maturation in preterm newborns. J Pediatr. 2003 Jul;143(1):31-8. doi: 10.1016/S0022-3476(03)00242-7.
PubMed 12915821Jadcherla SR, Hoffmann RG, Shaker R. Effect of maturation of the magnitude of mechanosensitive and chemosensitive reflexes in the premature human esophagus. J Pediatr. 2006 Jul;149(1):77-82. doi: 10.1016/j.jpeds.2006.02.041.
PubMed 16860132Jadcherla SR, Gupta A, Stoner E, Coley BD, Wiet GJ, Shaker R. Correlation of glottal closure using concurrent ultrasonography and nasolaryngoscopy in children: a novel approach to evaluate glottal status. Dysphagia. 2006 Jan;21(1):75-81. doi: 10.1007/s00455-005-9002-7.
PubMed 16786412Jadcherla SR. Manometric evaluation of esophageal-protective reflexes in infants and children. Am J Med. 2003 Aug 18;115 Suppl 3A:157S-160S. doi: 10.1016/s0002-9343(03)00215-8.
PubMed 12928093Jadcherla SR, Duong HQ, Hofmann C, Hoffmann R, Shaker R. Characteristics of upper oesophageal sphincter and oesophageal body during maturation in healthy human neonates compared with adults. Neurogastroenterol Motil. 2005 Oct;17(5):663-70. doi: 10.1111/j.1365-2982.2005.00706.x.
PubMed 16185304Gupta A, Jadcherla SR. The relationship between somatic growth and in vivo esophageal segmental and sphincteric growth in human neonates. J Pediatr Gastroenterol Nutr. 2006 Jul;43(1):35-41. doi: 10.1097/01.mpg.0000226368.24332.50.
PubMed 16819375
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Motility and Airway Defenses Among Infants
- ClinicalTrials.gov ID
- NCT00062452
- Acronym / sponsor ID
- EMADAI (completed)
- Keywords
- Esophageal, Airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Children's National Research Institute
- Study start
- May 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 6 Jun 2003 (estimated)
- 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.
Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function. Prematurity, congenital anomalies and perinatal depression represent three important conditions in infants, that may have feeding and airway difficulties.Development of motility of the foregut and the adaptation during normal and disease in developing infants is unclear.
Detailed description
With the aid of small clinical research funding from the NIDDK, in this proposal, we have developed methods to safely evaluate foregut motility in relation to breathing among high risk infants. We are using simultaneous esophageal motility studies, swallowing and respiratory measurements in this evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A-1,2,3 | – | –The cohort (A) comprised of high risk infants. There were 3 sub groups studied within this cohort: (1) premature infants, (2) Infants with congenital gut anomalies, and (3) perinatal asphyxia. |
Who may qualify
- Ages
- 2 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature infants congenital foregut anomalies Perinatal asphyxia
Key inclusion criteria (1 listed)
- Prematurely born infants, Infants with congenital foregut anomalies, Infants with perinatal asphyxia, Ability to maintain vital signs at study,
Key exclusion criteria (1 listed)
- No contraindication to enteral feeding
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
Not reported in the source record.
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 6 Oct 2017.
- Results publication: PubMed 12915821Jadcherla SR, Duong HQ, Hoffmann RG, Shaker R. Esophageal body and upper esophageal sphincter motor responses to esophageal provocation during maturation in preterm newborns. J Pediatr. 2003 Jul;143(1):31-8. doi: 10.1016/S0022-3476(03)00242-7.
- Results publication: PubMed 16860132Jadcherla SR, Hoffmann RG, Shaker R. Effect of maturation of the magnitude of mechanosensitive and chemosensitive reflexes in the premature human esophagus. J Pediatr. 2006 Jul;149(1):77-82. doi: 10.1016/j.jpeds.2006.02.041.
- Results publication: PubMed 16786412Jadcherla SR, Gupta A, Stoner E, Coley BD, Wiet GJ, Shaker R. Correlation of glottal closure using concurrent ultrasonography and nasolaryngoscopy in children: a novel approach to evaluate glottal status. Dysphagia. 2006 Jan;21(1):75-81. doi: 10.1007/s00455-005-9002-7.
- Results publication: PubMed 12928093Jadcherla SR. Manometric evaluation of esophageal-protective reflexes in infants and children. Am J Med. 2003 Aug 18;115 Suppl 3A:157S-160S. doi: 10.1016/s0002-9343(03)00215-8.
- Results publication: PubMed 16185304Jadcherla SR, Duong HQ, Hofmann C, Hoffmann R, Shaker R. Characteristics of upper oesophageal sphincter and oesophageal body during maturation in healthy human neonates compared with adults. Neurogastroenterol Motil. 2005 Oct;17(5):663-70. doi: 10.1111/j.1365-2982.2005.00706.x.
- Results publication: PubMed 16819375Gupta A, Jadcherla SR. The relationship between somatic growth and in vivo esophageal segmental and sphincteric growth in human neonates. J Pediatr Gastroenterol Nutr. 2006 Jul;43(1):35-41. doi: 10.1097/01.mpg.0000226368.24332.50.
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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.
Sudarshan R Jadcherla, MD principal investigator
Nationwide Children's Hospital/The Ohio State University 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 Infant, Premature, Diseases and Congenital Abnormalities, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 1 inclusion and 1 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 6 Oct 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00062452, which also lists 6 linked publications.
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 Oct 2017.