Compromised airway in children with congenital mandibular hypoplasia

Compromised airway in children with congenital mandibular hypoplasia - Mandibular hypoplasia and airway

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45263

Enrollment

Registered

2017-06-13

Start date

2017-06-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular hypoplasia / short lower jaw

Interventions

Mandibular hypoplasia

Quality of life

Respiratory distress

Sleep-disordered breathing

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Mandibular hypoplasia and symptoms of respiratory distress Age below 17 years

Exclusion criteria

Exclusion criteria: No informed consent Patient or parent(s) or guardian(s) do not speak Dutch

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)