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Orofacial Development of Preterm and Low Birthweight Infants Versus Term Infants

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ClinicalTrials.gov Identifier: NCT00408746
Recruitment Status : Unknown
Verified February 2007 by University Hospital Muenster.
Recruitment status was:  Recruiting
First Posted : December 7, 2006
Last Update Posted : March 24, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Premature Birth Infant, Newborn Pregnancy Behavioral: palatal development

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Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2003
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Behavioral: palatal development
    Impressions of preterm and term palates.

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Caucasian preterm and term babies

Inclusion Criteria:

  • infants of the tertiary care level University Hospital of Münster
  • delivery between May 1999 and December 2008
  • caucasian origin
  • written informed consent by both parents

Exclusion Criteria:

  • history of orotracheal intubation / orogastric tube feeding
  • hydrocephalus
  • palatal cleft, congenital syndrome, head / neck malformation
  • congenital metabolic disease beyond osteopenia of prematurity
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408746

Contact: Ariane Hohoff, PD Dr. ++49 251 8347102 hohoffa@uni-muenster.de
Contact: Thomas Stamm, PD Dr. ++49 251 8347101 stammt@uni-muenster.de

Universitätsklinikum Münster Recruiting
Münster, NRW, Germany, 48129
Contact: Ariane Hohoff, PD Dr.    0049 251 8347102    hohoffa@uni-muenster.de   
Contact: Thomas Stamm, PD Dr.    0049 251 8347101    stammt@uni-muenster.de   
Sub-Investigator: Thomas Stamm, PD Dr.         
Sub-Investigator: Heike Rabe, PD Dr.         
Sub-Investigator: Isabell Hörning-Franz, Dr.         
Sub-Investigator: Ulrike Ehmer, Prof. Dr.         
Sub-Investigator: Erik Harms, Prof. Dr.         
Sponsors and Collaborators
University Hospital Muenster
NUK Baby Care, Mapa GmbH, Industriestrasse 21-25, 27404 Zeven
TOP-Service für Lingualtechnik GmbH, Lindenstr. 42, 49152 Bad Essen
Principal Investigator: Ariane Hohoff, PD Dr. Universitätsklinikum Münster, Germany
More Information