Orofacial Development of Preterm and Low Birthweight Infants Versus Term Infants
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| First Received Date ICMJE | December 6, 2006 | ||||||||
| Last Updated Date | March 23, 2009 | ||||||||
| Start Date ICMJE | January 2003 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00408746 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Orofacial Development of Preterm and Low Birthweight Infants Versus Term Infants | ||||||||
| Official Title ICMJE | Prospective (Multicentre) Epidemiologic Longitudinal Study of Orofacial Development of Preterm and Low Birthweight Infants Compared to Term Infants in Consideration of Perinatal, Biometrical, Nutritional, Functional and Parental Parameters | ||||||||
| Brief Summary | Preterm infants account for 6 % of all live-births in western societies. Scientific evidence can be found for altered palatal morphology in the short term among preterm children. Oral intubation and orogastric feeding might be contributing factors to these alterations, but it has not been examined whether in the absence of these interventions preterm infants' palates are altered a priori as compared to term infants, e.g. due to immaturity of the bones or due to immaturity of oral function. Because of contradictory results, lack of longitudinal and high quality standard studies, the scientific evidence is also to weak to answer the question whether premature birth without or with a history of orotracheal intubation and orogastric feeding causes permanent alteration of orofacial development. The aim of the present study, therefore is to investigate in consideration of perinatal, biometrical, nutritional, functional and parental parameters. |
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| Detailed Description | Preterm infants account for 6 % of all live-births in western societies. Scientific evidence can be found for altered palatal morphology in the short term among preterm children. Oral intubation and orogastric feeding might be contributing factors to these alterations, but it has not been examined whether in the absence of these interventions preterm infants' palates are altered a priori as compared to term infants, e.g. due to immaturity of the bones or due to immaturity of oral function. Because of contradictory results, lack of longitudinal and high quality standard studies, the scientific evidence is also to weak to answer the question whether premature birth without or with a history of orotracheal intubation and orogastric feeding causes permanent alteration of orofacial development. The aim of the present study, therefore is to investigate in consideration of perinatal, biometrical, nutritional, functional and parental parameters
The participants must meet the following inclusion criteria: all:
preterm infants (will be allocated in two groups depending on the absence or presence of a history of orotracheal intubation and orogastric feeding):
Exclusion criteria are hydrocephalus, oral or facial clefts, congenital syndrome, deformity of the head and neck and congenital metabolic disease beyond osteopenia of prematurity. The children will be examined at the following times:
The following measures will be taken at all times: child:
child and parents: - smear of the oral mucosa. The following measures will be taken once (at time of discharge from hospital): child:
The following measures will be taken at the investigation times during the time the child is breast or bottle fed (measures stopped at the latest when the child has a corrected age of twelve months: child:
The following measures will be taken at a corrected age of 36 and 50 months: child: - alginate impression of the lower jaw, wax bite. As a positive side effect the database -beyond the primary aim of the study- will be useful in evaluating the influence of hereditary, perinatal, functional and nutritional parameters on orofacial development in general, it will serve as control data for therapies in patients with craniofacial defects (e.g. clefts) and provide a basis for development of physiologic pacifying, feeding and intensive care devices. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Caucasian preterm and term babies |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: palatal development
Impressions of preterm and term palates. |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 5 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00408746 | ||||||||
| Other Study ID Numbers ICMJE | KFO-MAPA-1/2006 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Priv.-Doz. Dr. Ariane Hohoff, University Hospital Muenster | ||||||||
| Study Sponsor ICMJE | University Hospital Muenster | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital Muenster | ||||||||
| Verification Date | February 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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