Premature BirthNCT00408746
Orofacial Development of Preterm and Low Birthweight Infants Versus Term Infants
An observational study of Premature Birth and Infant, Newborn, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Infant, Newborn, Pregnancy
- What is being tested?
- palatal development
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Caucasian preterm and term babies
Who may be able to join
- 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
Who cannot join
- history of orotracheal intubation / orogastric tube feeding
- hydrocephalus
- palatal cleft, congenital syndrome, head / neck malformation
- congenital metabolic disease beyond osteopenia of prematurity
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48129
Ariane Hohoff, PD Dr., 0049 251 8347102, hohoffa@uni-muenster.de
Thomas Stamm, PD Dr., 0049 251 8347101, stammt@uni-muenster.de
About this study
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
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.
Read the 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
- 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, length/height, head circumference), nutritional and functional parameters (breast/bottle/spoon 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 (e.g. clefts) and provide a basis for development of physiologic pacifying, feeding and intensive care devices.
- Conditions
- Premature Birth, Infant, Newborn, Pregnancy
- Being tested
- palatal development
- Keywords
- stomatognathic system, maxilla, palate, development
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palatal developmentBehavioural
Impressions of preterm and term palates.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startJan 2003
- Primary completionJan 2012 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- NUK Baby Care, Mapa GmbH, Industriestrasse 21-25, 27404 Zeven, TOP-Service für Lingualtechnik GmbH, Lindenstr. 42, 49152 Bad Essen
- Investigators
- Ariane Hohoff, PD Dr., Principal investigator, Universitätsklinikum Münster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408746
- Sponsor's protocol ID
- KFO-MAPA-1/2006
- Status last verified
- Feb 2007
- First submitted
- 6 Dec 2006
- Last updated
- 24 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hohoff A, Rabe H, Ehmer U, Harms E. Palatal development of preterm and low birthweight infants compared to term infants - What do we know? Part 1: The palate of the term newborn. Head Face Med. 2005 Oct 28;1:8. doi: 10.1186/1746-160X-1-8.
PubMed 16270908Hohoff A, Rabe H, Ehmer U, Harms E. Palatal development of preterm and low birthweight infants compared to term infants - What do we know? Part 2: The palate of the preterm/low birthweight infant. Head Face Med. 2005 Oct 28;1:9. doi: 10.1186/1746-160X-1-9.
PubMed 16270909Hohoff A, Rabe H, Ehmer U, Harms E. Palatal development of preterm and low birthweight infants compared to term infants -- What do we know? Part 3: discussion and conclusion. Head Face Med. 2005 Nov 2;1:10. doi: 10.1186/1746-160X-1-10.
PubMed 16270912Hohoff A, Stamm T, Meyer U, Wiechmann D, Ehmer U. Objective growth monitoring of the maxilla in full term infants. Arch Oral Biol. 2006 Mar;51(3):222-35. doi: 10.1016/j.archoralbio.2005.07.007. Epub 2005 Aug 31.
PubMed 16139239Hohoff A, Bosse L, Stamm T, Schmid JQ, Kanemeier M. Timing of primary maxillary tooth eruption in preterm compared to term infants: a retrospective longitudinal cohort study. BMC Oral Health. 2026 Jun 16;26(1):1064. doi: 10.1186/s12903-026-08851-0.
PubMed 42304284
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00408746
- Acronym / sponsor ID
- KFO-MAPA-1/2006
- Conditions
- Premature Birth, Infant, Newborn, Pregnancy
- Keywords
- stomatognathic system, maxilla, palate, development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- NUK Baby Care, Mapa GmbH, Industriestrasse 21-25, 27404 Zeven, TOP-Service für Lingualtechnik GmbH, Lindenstr. 42, 49152 Bad Essen
- Study start
- Jan 2003
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 7 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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, length/height, head circumference), nutritional and functional parameters (breast/bottle/spoon 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 (e.g. clefts) and provide a basis for development of physiologic pacifying, feeding and intensive care devices.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Caucasian preterm and term babies
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- history of orotracheal intubation / orogastric tube feeding
- hydrocephalus
- palatal cleft, congenital syndrome, head / neck malformation
- congenital metabolic disease beyond osteopenia of prematurity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palatal developmentImpressions of preterm and term palates. | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
- Background: PubMed 16270908Hohoff A, Rabe H, Ehmer U, Harms E. Palatal development of preterm and low birthweight infants compared to term infants - What do we know? Part 1: The palate of the term newborn. Head Face Med. 2005 Oct 28;1:8. doi: 10.1186/1746-160X-1-8.
- Background: PubMed 16270909Hohoff A, Rabe H, Ehmer U, Harms E. Palatal development of preterm and low birthweight infants compared to term infants - What do we know? Part 2: The palate of the preterm/low birthweight infant. Head Face Med. 2005 Oct 28;1:9. doi: 10.1186/1746-160X-1-9.
- Background: PubMed 16270912Hohoff A, Rabe H, Ehmer U, Harms E. Palatal development of preterm and low birthweight infants compared to term infants -- What do we know? Part 3: discussion and conclusion. Head Face Med. 2005 Nov 2;1:10. doi: 10.1186/1746-160X-1-10.
- Background: PubMed 16139239Hohoff A, Stamm T, Meyer U, Wiechmann D, Ehmer U. Objective growth monitoring of the maxilla in full term infants. Arch Oral Biol. 2006 Mar;51(3):222-35. doi: 10.1016/j.archoralbio.2005.07.007. Epub 2005 Aug 31.
- Derived from this study: PubMed 42304284Hohoff A, Bosse L, Stamm T, Schmid JQ, Kanemeier M. Timing of primary maxillary tooth eruption in preterm compared to term infants: a retrospective longitudinal cohort study. BMC Oral Health. 2026 Jun 16;26(1):1064. doi: 10.1186/s12903-026-08851-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariane Hohoff, PD Dr. principal investigator
Universitätsklinikum Münster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Infant, Newborn, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane Hohoff, PD Dr. (++49 251 8347102, hohoffa@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00408746, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2009.