Primary Objective: 1: To determine the severity of respiratory problems, treatment modalities and outcome in the first year of life. Secondary Objectives:2a: To evaluate the course of respiratory problems and quality of life on long term follow-up.…
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A standardised questionnaire combined with clinical examination and
ENT-examination (The Sleep Clinical Record) will be used to assess the clinical
signs of possible respiratory problems. Respiratory problems are assessed with
a polysomnography. The outcome measurements of the polysomnography will be
described by the Obstructive Apnea Hypopnea Index (OAHI) and the Oxygen
Desaturation Index (ODI). An OAHI of 1-4 events/hour (mild), OAHI of 5-10
(moderate) and an OAHI of > 10 (severe) will be used to describe the severity
of sleep-disordered breathing (SDB).
Secondary outcome
The relation between SDB and symptoms of respiratory distress during the day
will be assessed by evaluating clinical records and by specific questions
focussing on respiratory distress.
The Sleep Clinical Record, Pediatric Sleep Questionnaire (PSQ) and Brief Infant
Sleep Questionnaire (BISQ) will be used to assess the clinical signs of
respiratory problems and possible SDB. If the Sleep Clinical Record results in
a score of higher than 6.5, the child is considered to be at risk for SDB.
The Infant Toddler Quality of Life questionnaire (ITQoL), the Child Health
Questionnaire (CHQ) and the 36- and 12-item Short Form Survey (SF-36 and SF-12)
will be used to assess quality of life.
The OSA-18 and OSA-12 questionnaires will be used to assess obstructive sleep
apnea (OSA) related quality of life.
The growth of the mandible will be assessed using three-dimensional
stereophotogrammetry.
The outcomes of the anthropometric measurements will be noted in centimetres
and standard deviation (head circumference and length) and kilograms and
standard deviation (weight). These outcomes will be compared to Dutch reference
growth charts for children (Growth Analyzer).
Background summary
A common problem in children with a congenital mandibular hypoplasia are
respiratory problems due to an upper airway obstruction. This obstruction may
be caused at the level of the nasopharynx and/or the tongue base. A screening
program and prompt effective treatment by a specialised craniofacial team are
important aspects for successful care for these children. This study will focus
on patients with mandibular hypoplasia and respiratory symptoms.
Study objective
Primary Objective:
1: To determine the severity of respiratory problems, treatment modalities and
outcome in the first year of life.
Secondary Objectives:
2a: To evaluate the course of respiratory problems and quality of life on long
term follow-up.
2a: To evaluate prevalence, characteristics and management of feeding
difficulties.
2c: To determine the growth pattern of the lower face in relation to the upper
airway
Study design
Observational prospective cohort study.
Study burden and risks
Investment from patient/carer perspective upon participation in this study is
the extra time necessary to fill out the questionnaires, one extra ENT-exam as
part of the evaluation of the airway (part of the scoring system of the Sleep
Clinical Record) and one extra examination of swallowing function by a speech
therapist. All measurements (as described in the study procedures protocol) are
non-invasive and part of standard clinical procedure. No adverse events are to
be expected.
Participation has no direct benefit for the participants, since all
measurements performed are part of standard clinical care.
Parent(s)/guardian(s) and children in both the study population and the control
population will be asked thirteen times to fill out questionnaires in total.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Mandibular hypoplasia and symptoms of respiratory distress
Age below 17 years
Exclusion criteria
No informed consent
Patient or parent(s) or guardian(s) do not speak Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60496.078.17 |