Orofacial Development of Preterm and Low Birthweight Infants Versus Term Infants
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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
University Hospital Muenster
NUK Baby Care, Mapa GmbH, Industriestrasse 21-25, 27404 Zeven
TOP-Service für Lingualtechnik GmbH, Lindenstr. 42, 49152 Bad Essen
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.
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 :
Estimated Primary Completion Date :
Estimated Study Completion Date :
Resource links provided by the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
up to 5 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Caucasian preterm and term babies
infants of the tertiary care level University Hospital of Münster
delivery between May 1999 and December 2008
written informed consent by both parents
history of orotracheal intubation / orogastric tube feeding
palatal cleft, congenital syndrome, head / neck malformation
congenital metabolic disease beyond osteopenia of prematurity