1
40
2
-
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Treatment of Symptoms in Children with Q3 Conditions Scoping Review Results
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.3310/hta16400" target="_blank" rel="noreferrer noopener">http://doi.org/10.3310/hta16400</a>
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
The use of Melatonin in children with Neurodevelopmental Disorders and impaired Sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS)
Publisher
An entity responsible for making the resource available
Health Technology Assessment
Date
A point or period of time associated with an event in the lifecycle of the resource
2012
Subject
The topic of the resource
insomnia; Health Care Sciences & Services; autism spectrum disorders; controlled-trial; exogenous melatonin; handicapped-children; improves sleep; onset; phase; rett-syndrome; serum melatonin; syndrome; young-adults; sleep disturbance/disorders; neurodevelopmental disorders; pharmacologic intervention; melatonin
Creator
An entity primarily responsible for making the resource
Appleton R E; Jones A P; Gamble C; Williamson P R; Wiggs L; Montgomery P; Sutcliffe A; Barker C; Gringras P
Description
An account of the resource
Background: Difficulties in initiating and maintaining sleep are common in children with neurodevelopmental disorders. Melatonin is unlicensed in children yet widely prescribed for sleep problems. Objective: To determine whether or not immediate-release melatonin is beneficial compared with placebo in improving total duration of night-time sleep in children with neurodevelopmental problems. Design: Randomised, double-blind, placebo-controlled, parallel study. Setting: Hospitals throughout England and Wales recruited patients referred by community paediatricians and other clinical colleagues. Participants: Children with neurodevelopmental problems aged from 3 years to 15 years 8 months who did not fall asleep within 1 hour of lights out or who had <6 hours of continuous sleep. Before randomisation, patients meeting eligibility criteria entered a 4- to 6-week behaviour therapy period in which a behaviour therapy advice booklet was provided. Sleep was measured using sleep diaries and actigraphy. After this period the sleep diaries were reviewed to determine if the sleep problem fulfilled the eligibility criteria. Eligible participants were randomised and followed for 12 weeks. Interventions: Melatonin or placebo capsules in doses of 0.5 mg, 2 mg, 6mg and 12 mg for a period of 12 weeks. The starting dose was 0.5 mg and the dose could be escalated through 2 mg and 6 mg to 12 mg during the first 4 weeks, at the end of which the child was maintained on that dose. Main outcome measures: The primary outcome was total night-time sleep time (TST) calculated using sleep diaries at 12 weeks compared with baseline. Secondary outcome measures included TST calculated using actigraphy data, sleep-onset latency (SOL) (time taken to fall asleep), sleep efficiency, Composite Sleep Disturbance Index score, global measure of child's sleep quality, Aberrant Behaviour Checklist, Family Impact Module of the Pediatric Quality of Life Inventory (PedsQL (TM)), the Epworth Sleepiness Scale, number and severity of seizures and adverse events. Salivary melatonin concentrations and association of genetic variants with abnormal melatonin production were also investigated. Results: A total of 275 children were screened to enter the trial; 263 (96%) children were registered and completed the 4- to 6-week behaviour therapy period and 146 (56%) children were randomised, of whom 110 (75%) contributed data for the primary outcome. The difference in TST time between the melatonin and placebo groups adjusted for baseline was 22.43 minutes [95% confidence interval (Cl) 0.52 to 44.34 minutes; p = 0.04] measured using sleep diaries. A reduction in SOL, adjusted for baseline, was seen for melatonin compared with placebo when measured by sleep diaries (-37.49 minutes, 95% CI -55.27 to -19.71 minutes; p < 0.0001) and actigraphy (-45.34 minutes, 95% CI -68.75 to -21.93 minutes; p=0.0003). There were no significant differences between the two groups in terms of the reporting of adverse events. The results of other secondary outcomes favoured melatonin but were not statistically significant. Conclusions: On average, the children treated with melatonin slept 23 minutes longer than those in the placebo group; however, the upper limit of the confidence interval was less than 1 hour, the minimum clinically worthwhile difference specified at the outset of the trial. Melatonin is effective in reducing SOL in children with neurodevelopmental delay by a mean of 45 minutes; a value of 30 minutes was specified a priori to be clinically important. Future studies should be conducted over longer periods and directly compare different formulations of melatonin with conventional hypnotic and sedative medications. It would also be important to study groups of children with specific neurological disorders. Trial registration: Current Controlled Trials ISRCTN05534585.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.3310/hta16400" target="_blank" rel="noreferrer noopener">10.3310/hta16400</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
2012
Appleton R E
autism spectrum disorders
Barker C
CONTROLLED-TRIAL
exogenous melatonin
Gamble C
Gringras P
handicapped-children
Health Care Sciences & Services
Health Technology Assessment
improves sleep
insomnia
Jones A P
melatonin
Montgomery P
neurodevelopmental disorders
onset
pharmacologic intervention
phase
rett-syndrome
serum melatonin
sleep disturbance/disorders
Sutcliffe A
Syndrome
Wiggs L
Williamson P R
young-adults
-
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Treatment of Symptoms in Children with Q3 Conditions Scoping Review Results
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1136/bmj.e6664" target="_blank" rel="noreferrer noopener">http://doi.org/10.1136/bmj.e6664</a>
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo controlled trial
Publisher
An entity responsible for making the resource available
British Medical Journal
Date
A point or period of time associated with an event in the lifecycle of the resource
2012
Subject
The topic of the resource
Male; Treatment Outcome; Severity of Illness Index; Dose-Response Relationship Drug; Child; Humans; Adolescent; Family Health; Female; Child Preschool; Drug Monitoring; Child Behavior/drug effects; Melatonin/administration & dosage/adverse effects; Sleep Wake Disorders/diagnosis/drug therapy/etiology; Central Nervous System Depressants/administration & dosage/adverse effects; Central Nervous System Diseases/complications; Developmental Disabilities/complications; Polysomnography/methods; Sleep/drug effects; sleep disturbance/disorders; unspecified Q3 conditions; Q3 conditions; pharmacologic intervention; melatonin
Creator
An entity primarily responsible for making the resource
Gringras P; Gamble C; Jones A P; Wiggs L; Williamson P R; Sutcliffe A; Montgomery P; Whitehouse W P; Choonara I; Allport T; Edmond A; Appleton R
Description
An account of the resource
OBJECTIVE: To assess the effectiveness and safety of melatonin in treating severe sleep problems in children with neurodevelopmental disorders. DESIGN: 12 week double masked randomised placebo controlled phase III trial. SETTING: 19 hospitals across England and Wales. PARTICIPANTS: 146 children aged 3 years to 15 years 8 months were randomised. They had a range of neurological and developmental disorders and a severe sleep problem that had not responded to a standardised sleep behaviour advice booklet provided to parents four to six weeks before randomisation. A sleep problem was defined as the child not falling asleep within one hour of lights out or having less than six hours' continuous sleep. INTERVENTIONS: Immediate release melatonin or matching placebo capsules administered 45 minutes before the child's bedtime for a period of 12 weeks. All children started with a 0.5 mg capsule, which was increased through 2 mg, 6 mg, and 12 mg depending on their response to treatment. MAIN OUTCOME MEASURES: Total sleep time at night after 12 weeks adjusted for baseline recorded in sleep diaries completed by the parent. Secondary outcomes included sleep onset latency, assessments of child behaviour, family functioning, and adverse events. Sleep was measured with diaries and actigraphy. RESULTS: Melatonin increased total sleep time by 22.4 minutes (95% confidence interval 0.5 to 44.3 minutes) measured by sleep diaries (n=110) and 13.3 (-15.5 to 42.2) measured by actigraphy (n=59). Melatonin reduced sleep onset latency measured by sleep diaries (-37.5 minutes, -55.3 to -19.7 minutes) and actigraphy (-45.3 minutes, -68.8 to -21.9 minutes) and was most effective for children with the longest sleep latency (P=0.009). Melatonin was associated with earlier waking times than placebo (29.9 minutes, 13.6 to 46.3 minutes). Child behaviour and family functioning outcomes showed some improvement and favoured use of melatonin. Adverse events were mild and similar between the two groups. CONCLUSIONS: Children gained little additional sleep on melatonin; though they fell asleep significantly faster, waking times became earlier. Child behaviour and family functioning outcomes did not significantly improve. Melatonin was tolerable over this three month period. Comparisons with slow release melatonin preparations or melatonin analogues are required. TRIAL REGISTRATION: ISRCT No 05534585.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1136/bmj.e6664" target="_blank" rel="noreferrer noopener">10.1136/bmj.e6664</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
2012
Adolescent
Allport T
Appleton R
British Medical Journal
Central Nervous System Depressants/administration & dosage/adverse effects
Central Nervous System Diseases/complications
Child
Child Preschool
Child Behavior/drug effects
Choonara I
Developmental Disabilities/complications
Dose-Response Relationship Drug
Drug Monitoring
Edmond A
Family Health
Female
Gamble C
Gringras P
Humans
Jones A P
Male
melatonin
Melatonin/administration & dosage/adverse effects
Montgomery P
pharmacologic intervention
Polysomnography/methods
Q3 conditions
Severity Of Illness Index
sleep disturbance/disorders
Sleep Wake Disorders/diagnosis/drug therapy/etiology
Sleep/drug effects
Sutcliffe A
Treatment Outcome
unspecified Q3 conditions
Whitehouse W P
Wiggs L
Williamson P R