Cleft LipNCT00097149
Systematic Pediatric Care for Oral Clefts - South America
A study testing Systematic pediatric care in people with Cleft Lip and Cleft Palate, run by NICHD Global Network for Women's and Children's Health at 1 site in Brazil.
Trial summary
Cleft lip and palate are a significant component of morbid human birth defects in the developing world. This study measures the impact of having a child born with a cleft lip on subsequent maternal/infant family health, and whether frequent pediatric care compared to standard pediatric care will reduce neonatal… Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Cleft Lip, Cleft Palate, Congenital Defects
- What is being tested?
- Systematic pediatric care
- Type of treatment
- Surgery or procedure
- How many people
- 696 participants
- Where
- 1 siteBrazil
- Study dates
- May 2003to May 2006
- Phase
- Interventional
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Subproject A:
- All children born with an oral cleft in a participating hospital (hospitals in Argentina, Bolivia, Brazil, Chile, Colombia and Venezuela affiliated with ECLAMC)
Subproject B: Cases from Subproject A that meet the following criteria:
- Cleft lip with or without cleft palate or cleft palate only
- Birth weight >2500 g
- No other identifiable birth defect: nonsyndromic
- Singleton (nonmultiple birth)
- No other complications requiring systematic care
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Latin-American Collaborative Study of Congenital Malformations (ECLAMC)
Rio de Janeiro
About this study
Cleft lip and palate are a significant component of morbid human birth defects in the developing world. This study measures the impact of having a child born with a cleft lip on subsequent maternal/infant family health, and whether frequent pediatric care compared to standard pediatric care will reduce neonatal mortality in children born with cleft lip and palate.
Read the detailed description
Craniofacial anomalies and cleft lip with or without cleft palate (CL/P) are a model for the impact of birth defects on fetal and neonatal health directly and maternal health indirectly. Craniofacial anomalies comprise a significant component of morbid human birth defects. This study is composed of two Subprojects, A and B. Subproject A involves provision of intensive pediatric care over the first 28 days of life for a prospective group of about 694 cleft cases, which will be compared to a retrospective group of about 464 cleft cases. Nonsyndromic cleft lip with or without cleft palate (NSCL/P) cases (about 264 cases) of Subproject A will be randomized into two groups: intervened (about 132 cases) and non-intervened (about 132 cases). Sub-project B involves provision of systematic pediatric care over a 2-year period for the intervened group. This group will be compared to the non-intervened group in order to study the effect of the intervention on the neurodevelopment and physical health of the child as well as the emotional and social health of the family. The standard care group also will be compared to a group of about 264 healthy controls, matched by sex and place and date of birth in order to study the impact of the cleft on the physical health and neurodevelopment of the child as well as the emotional and social health of the family. The importance of the study relates to the substantial burden caused by clefts and the necessity of developing and testing approaches that may lessen this burden. The outcomes of this project will be to further strengthen collaborative relationships in the area of craniofacial anomalies between South America and the United States; to better understand the effects of birth defects, and craniofacial anomalies in particular, on maternal family units; and, to decrease the burden of these defects directly. The sample size was based on an expected overall 28 days mortality rate among cleft infants that is around 0.25, calculated at a 0.05 significance level.
- Conditions
- Cleft Lip, Cleft Palate, Congenital Defects
- Being tested
- Systematic pediatric care
- Keywords
- Congenital birth defects, Cleft lip, Cleft palate, Global Network, Neurodevelopmental outcome, Maternal and child health, International, Women's health, Brazil, Brasil, Latin America, ECLAMC, Argentina, Bolivia, Chile, Colombia, Ecuador, Venezuela
- Medical subject headings
- Cleft Lip, Cleft Palate, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic pediatric careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
SUBPROJECT A: Neonatal mortality
SUBPROJECT B: Neurodevelopmental outcome
Weight
Secondary outcomes (2)
SUBPROJECT A: Hospitalizations, Weight
SUBPROJECT B: Height, Speech, Hearing, Mortality, Cleft surgery, Rate of weight gain, Financial burden, Syndromic classification, Emotional and social family development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2004 (estimated)
- Study startMay 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cleft LipStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 696 participants
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, National Institute of Dental and Craniofacial Research (NIDCR), Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), RTI International, University of Iowa, Latin-American Collaborative Study of Congenital Malformations (ECLAMC)
- Responsible party
- Sponsor
- Investigators
- Jeff Murray, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097149
- Sponsor's protocol ID
- GN 04 Aim II
- Other IDs
- U01HD040561
- Status last verified
- Dec 2013
- First submitted
- 17 Nov 2004
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, Kindem M, Chakraborty H, Dutra G, Lopez-Camelo JS, Orioli IM, Murray JC. The effect of systematic pediatric care on neonatal mortality and hospitalizations of infants born with oral clefts. BMC Pediatr. 2011 Dec 28;11:121. doi: 10.1186/1471-2431-11-121.
PubMed 22204448Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, McCarthy AM, Bobashev G, Litavecz S, Mariona A, Dutra G, Lopez-Camelo JS, Orioli IM, Murray JC. Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]. BMC Pediatr. 2006 Mar 24;6:9. doi: 10.1186/1471-2431-6-9.
PubMed 16563165
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Pediatric Care for Oral Clefts - South America
- ClinicalTrials.gov ID
- NCT00097149
- Acronym / sponsor ID
- GN 04 Aim II
- Conditions
- Cleft Lip, Cleft Palate, Congenital Defects
- Keywords
- Congenital birth defects, Cleft lip, Cleft palate, Global Network, Neurodevelopmental outcome, Maternal and child health, International, Women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 696 participants
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, National Institute of Dental and Craniofacial Research (NIDCR), Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), RTI International, University of Iowa, Latin-American Collaborative Study of Congenital Malformations (ECLAMC)
- Study start
- May 2003
- Study completion
- May 2006 (actual)
- First posted
- 18 Nov 2004 (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.
Cleft lip and palate are a significant component of morbid human birth defects in the developing world. This study measures the impact of having a child born with a cleft lip on subsequent maternal/infant family health, and whether frequent pediatric care compared to standard pediatric care will reduce neonatal mortality in children born with cleft lip and palate.
Detailed description
Craniofacial anomalies and cleft lip with or without cleft palate (CL/P) are a model for the impact of birth defects on fetal and neonatal health directly and maternal health indirectly. Craniofacial anomalies comprise a significant component of morbid human birth defects. This study is composed of two Subprojects, A and B. Subproject A involves provision of intensive pediatric care over the first 28 days of life for a prospective group of about 694 cleft cases, which will be compared to a retrospective group of about 464 cleft cases. Nonsyndromic cleft lip with or without cleft palate (NSCL/P) cases (about 264 cases) of Subproject A will be randomized into two groups: intervened (about 132 cases) and non-intervened (about 132 cases). Sub-project B involves provision of systematic pediatric care over a 2-year period for the intervened group. This group will be compared to the non-intervened group in order to study the effect of the intervention on the neurodevelopment and physical health of the child as well as the emotional and social health of the family. The standard care group also will be compared to a group of about 264 healthy controls, matched by sex and place and date of birth in order to study the impact of the cleft on the physical health and neurodevelopment of the child as well as the emotional and social health of the family. The importance of the study relates to the substantial burden caused by clefts and the necessity of developing and testing approaches that may lessen this burden. The outcomes of this project will be to further strengthen collaborative relationships in the area of craniofacial anomalies between South America and the United States; to better understand the effects of birth defects, and craniofacial anomalies in particular, on maternal family units; and, to decrease the burden of these defects directly. The sample size was based on an expected overall 28 days mortality rate among cleft infants that is around 0.25, calculated at a 0.05 significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Systematic pediatric care | Procedure or surgery | – |
Primary outcome
SUBPROJECT A: Neonatal mortality
SUBPROJECT B: Neurodevelopmental outcome
Weight
2 secondary outcomes
SUBPROJECT A: Hospitalizations, Weight
SUBPROJECT B: Height, Speech, Hearing, Mortality, Cleft surgery, Rate of weight gain, Financial burden, Syndromic classification, Emotional and social family development
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 17 Dec 2013.
- Derived from this study: PubMed 22204448Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, Kindem M, Chakraborty H, Dutra G, Lopez-Camelo JS, Orioli IM, Murray JC. The effect of systematic pediatric care on neonatal mortality and hospitalizations of infants born with oral clefts. BMC Pediatr. 2011 Dec 28;11:121. doi: 10.1186/1471-2431-11-121.
- Derived from this study: PubMed 16563165Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, McCarthy AM, Bobashev G, Litavecz S, Mariona A, Dutra G, Lopez-Camelo JS, Orioli IM, Murray JC. Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]. BMC Pediatr. 2006 Mar 24;6:9. doi: 10.1186/1471-2431-6-9.
- Global Network for Women's and Children's Health ResearchLink provided by the sponsor.
- RTI InternationalLink provided by the sponsor.
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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.
Jeff Murray, M.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic pediatric care in people with Cleft Lip and Cleft Palate, run by NICHD Global Network for Women's and Children's Health at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Dec 2013. 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 Brazil. 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?
SUBPROJECT A: Neonatal mortality. 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 NCT00097149, which also lists 2 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 17 Dec 2013.