Orofacial Development of Preterm and Low Birthweight Infants Versus Term Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by University Hospital Muenster.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
NUK Baby Care, Mapa GmbH, Industriestrasse 21-25, 27404 Zeven
TOP-Service für Lingualtechnik GmbH, Lindenstr. 42, 49152 Bad Essen
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00408746
First received: December 6, 2006
Last updated: March 23, 2009
Last verified: February 2007
  Purpose

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 Intervention
Premature Birth
Infant, Newborn
Pregnancy
Behavioral: palatal development

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Estimated Enrollment: 80
Study Start Date: January 2003
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: palatal development
    Impressions of preterm and term palates.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Caucasian preterm and term babies

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408746

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

Locations
Germany
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
Investigators
Principal Investigator: Ariane Hohoff, PD Dr. Universitätsklinikum Münster, Germany
  More Information

Publications:
Responsible Party: Priv.-Doz. Dr. Ariane Hohoff, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00408746     History of Changes
Other Study ID Numbers: KFO-MAPA-1/2006
Study First Received: December 6, 2006
Last Updated: March 23, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
stomatognathic system
maxilla
palate
development

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on September 30, 2014