Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408746
Status:
UNKNOWN
Last Update Posted:
2009-03-24
First Post:
2006-12-06
Brief Title:
Orofacial Development of Preterm and Low Birthweight Infants Versus Term Infants
Sponsor:
University Hospital Muenster
Organization:
University Hospital Muenster
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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
whether preterm babies without a history of orotracheal intubation and orogastric feeding do have an altered orofacial development as compared to term babies
in a second step whether preterm babies with a history of orotracheal intubation and orogastric feeding do have an altered orofacial development as compared to preterm and term infants without these interventions
The participants must meet the following inclusion criteria
all
caucasian origin and
informed consent by both parents term infants
born at 37 weeks of gestation
birthweight 2500 g
preterm infants will be allocated in two groups depending on the absence or presence of a history of orotracheal intubation and orogastric feeding
gestational age at birth 25 weeks and
birthweight 500 g
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
2-5 days prior to discharge from hospital weight 1800 g in the preterm group
40 weeks of gestation 7 days tolerance
3 6 9 12 15 and 18 months of corrected age 28 days tolerance
24 36 48 and 60 months of corrected age 28 days tolerance
The following measures will be taken at all times
child
standardized questionnaire for evaluation of biometrical weight lengthheight head circumference nutritional and functional parameters breastbottlespoon feeding mode of breathing lip and tongue posture sucking habits kind of pacifiers and suckers
standardized frontal and lateral photographs
alginate impressions of the upper jaw
measurement of the overjet
child and parents - smear of the oral mucosa
The following measures will be taken once at time of discharge from hospital
child
standardized questionnaire concerning perinatal parameters parents
standardized questionnaire concerning parents orofacial history
standardized frontal and lateral photographs
alginate impressions of the both jaws and wax bite
measurement of the overjet
dental and periodontal findings
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
sucking of the child at an alginate filled condom
ultrasound of the feeding process
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 eg clefts and provide a basis for development of physiologic pacifying feeding and intensive care devices
The aim of the present study therefore is to investigate in consideration of perinatal biometrical nutritional functional and parental parameters
whether preterm babies without a history of orotracheal intubation and orogastric feeding do have an altered orofacial development as compared to term babies
in a second step whether preterm babies with a history of orotracheal intubation and orogastric feeding do have an altered orofacial development as compared to preterm and term infants without these interventions
The participants must meet the following inclusion criteria
all
caucasian origin and
informed consent by both parents term infants
born at 37 weeks of gestation
birthweight 2500 g
preterm infants will be allocated in two groups depending on the absence or presence of a history of orotracheal intubation and orogastric feeding
gestational age at birth 25 weeks and
birthweight 500 g
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
2-5 days prior to discharge from hospital weight 1800 g in the preterm group
40 weeks of gestation 7 days tolerance
3 6 9 12 15 and 18 months of corrected age 28 days tolerance
24 36 48 and 60 months of corrected age 28 days tolerance
The following measures will be taken at all times
child
standardized questionnaire for evaluation of biometrical weight lengthheight head circumference nutritional and functional parameters breastbottlespoon feeding mode of breathing lip and tongue posture sucking habits kind of pacifiers and suckers
standardized frontal and lateral photographs
alginate impressions of the upper jaw
measurement of the overjet
child and parents - smear of the oral mucosa
The following measures will be taken once at time of discharge from hospital
child
standardized questionnaire concerning perinatal parameters parents
standardized questionnaire concerning parents orofacial history
standardized frontal and lateral photographs
alginate impressions of the both jaws and wax bite
measurement of the overjet
dental and periodontal findings
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
sucking of the child at an alginate filled condom
ultrasound of the feeding process
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 eg clefts and provide a basis for development of physiologic pacifying feeding and intensive care devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None