Overview of clinical trial protocols for behavioral insomnia in infants

an analytical study that reviewed protocols registered with the International Clinical Trials Registry Platform between August and September 2019, aiming to identify the interventions for behavioral insomnia in infants, the comparators, the main primary, secondary outcomes and their respective measurements.

Results:

eleven protocols registered between 2004 and 2018 were included. Nurses were the main coordinators of protocols (45.5%), with proposals using educational technologies, one-to-one and online follow-up consultations. The main outcome was improvement of infant and maternal sleep patterns. Secondary outcomes were anxiety, depression, and parental sexual satisfaction. To measure them, the following were used: sleep diary (54.5%), actigraphy (45.4%), and the Pittsburgh Sleep Quality Interview (36.3%) and Extended Brief Infant Sleep Questionnaire (27.2%) were used.

Conclusion:

the protocols proposed interventions for independent sleep, aiming at quality of sleep for the whole family.

Descriptors:
Sleep; Sleep Initiation and Maintenance Disorders; Infant; Clinical Trial; Clinical Protocols

Protocol title (ICTRP), Country and year of registration	Interventions	Comparisons	Outcomes and Primary Measures	Outcomes and Secondary Measures
Effect Of An Educational-Behavioral Program About Infant Sleep Country: Iran Year: 2018	Lecture on general education and behavioral techniques^* * Behavioral technique/intervention: strategies that aim to teach the baby to fall asleep independently. for infant sleep for about 90 minutes.	30-minute lecture on child safety and sleep safety	- Amount of infant and maternal sleep, measured by the mother's and baby's sleep diary. - Quality of maternal sleep, measured by Pittsburgh Sleep Quality Interview (PSQI).	- Postnatal depression, measured by Edinburgh Postnatal Depression Scale (EPDS); - Maternal anxiety, measured by State Trait Anxiety; - Sexual satisfaction, measured by Hudson's Sexual Dysfunction Questionnaire).
The Efficacy of the Nanit-Insights App in Improving Infant Sleep Country: United States Year: 2018	Application that provides parents with personalized sleep recommendations based on the baby's stage of development and weekly sleep data.	Monitoring without application	- Quality of infant sleep, assessed by videosomnography and Extended Brief Infant Sleep Questionnaire.	- Quality of parents' sleep, measured by Pittsburgh Sleep Quality Index; and sleep duration, number of awakenings, time to wake up and night visits by parents, confirmed by videosomnography; - Parental humor, measured by the Clinically Useful Depression Outcome Scale.
Infant Behavioral Sleep Intervention: Comparative Efficacy Country: United States Year: 2018	(1) Routine adjustment + help from a sleep specialist + protocol of what parents do for children to start sleeping and in all possible awakenings at night; (2) Routine adjustment + help from a sleep specialist + protocol just to initiate sleep.	Monitoring	-Quality of children's sleep, measured by the Children's Sleep Questionnaire (ISQ).	- Duration of sleep, number of nighttime awakenings, assessed by sleep diary + videosomnography); - Parents' stress assessed by self-report; - Parental humor, measured by the Profile of Mood State); - Parents' sleep, measured by the Pittsburgh Sleep Quality Index).
Comparison of behavioral sleep interventions to reduce infant sleep disturbances and improve parental mental health Country: Australia Year: 2017	(1) Information leaflet on sleep physiology + nursing instruction to perform the gradual extinction technique; (2) Information leaflet on sleep physiology + instruction on how to teach children to sleep independently + not to leave the room and attend to children when asked.	Information leaflet on sleep physiology + instruction to answer questionnaires	- Night awakenings, assessed by actigraphy and parental self-report; - Levels of parental depression assessed, measured by Edinburgh Post Natal Depression.	- Attachment levels between parents and baby, measured by the Parental Attachment Questionnaire (PAQ); - Wear level, measured by the intervention participants' withdrawal); - Parents' stress levels, measured by Subjective Stress Scale (SUDS); - Babies' stress level measured by salivary cortisol.
Infant Sleep Hygiene Counseling Trial Country: Brazil Year: 2016	(1) Home visit for routine adjustment, sleep environment, sleep self-regulation practices and guidance for babies to be placed in the crib while still sleepy; (2) Actigraphy + home visit, intervention guidelines 1, sleep diary monitoring and telephone calls.	Home visits and delivery of material on breastfeeding	- Number of hours in a row in night sleep, measured by Brief Infant Sleep Questionnaire (BISQ).	- Linear growth, measured by anthropometry; - Neurocognitive development, measured by Intergrowth Neurodevelopment Assessment tool - INTER-NDA and the Oxford Neurodevelopment Assessment tool - OX-NDA).
Play2Sleep: Using Play to Improve Infant Sleep Country: Canada Year: 2016	Intervention through Play2Sleep Game with each parent separately. A recording is made, stimulating the bond between the parents and a leaflet on infant sleep is delivered.	Handout only	- Number of nighttime awakenings, measured by Brief Infant Sleep Questionnaire (BISQ).	- Parental depression, measured by Edinburgh Postnatal Depression Scale (EPDS); - Parental sense of competence, measured by Parental Sense of Competence (PSOC) Scale; - Marital satisfaction, measured by Dyadic Adjustment Scale (DAS-4); - Parent-child interactions, measured by Parent-Child Interaction Teaching Scale (PCITS); - Cognition of parents about baby sleep, measured by the Maternal Cognitions about Infant Sleep Questionnaire (MCISQ).
The impact o education on the fatigue and sleep disorders in the mother and infant in the postpartum period Country: Iran Year: 2015	(1) One-to-one training on the tenth day after birth (30-45 minutes) + daily text messages for 60 days. (2) Delivery of a CD with guidance on sleep on the tenth day after birth + daily text messages for 60 days.	Visit to answer the instruments, on the tenth and sixty days after birth	- Children's sleep quality: assessed by a sleep diary; - Quality of mothers' sleep, measured by Pittsburgh Sleep Quality. - Maternal fatigue: measured by Fatigue Intensity Questionnaire.	Not mentioned
A randomized controlled trial of behavioral interventions for infant sleep disturbance Country: Australia Year: 2012	Gradual extinction (placing the child awake in the crib, leaving the room and returning to warm up periodically), with routine adjustment and 24-hour follow-up for seven days.	Sleep education about time, naps and sleep environment in a 50-minute individual class	Sleep duration assessed by the sleep diary and actigraphy.	Child stress level assessed by salivary cortisol.
Tips for Infant and Parent Sleep (TIPS) Country: Canada Year: 2005	Behavioral interventions^* * Behavioral technique/intervention: strategies that aim to teach the baby to fall asleep independently. + sleep hygiene guidelines by nurses in the immediate postpartum period.	Follow-up only	- Duration of night sleep, assessed by a sleep diary and actigraphy; - Duration of naps: field diary and actigraphy; - Duration of maternal sleep: field diary and actigraphy.	- Morning and night fatigue, measured by Fatigue Visual Analogue Scale Fatigue (VAS); - Child sleep disorder, measured by General Sleep Disturbance Scale (GSDS). - Depressive symptoms, measured by Edinburgh Postnatal Depression Scale (EPDS); - Maternal anxiety, measured by State-Trait Anxiety Inventory, state-anxiety subscale.
Impact of an infant sleep parenting intervention at age 6 months on infant sleep problems at ages 6 to 12 months and maternal psychological and physical wellbeing Country: Australia Year: 2004	Behavioral interventions^* * Behavioral technique/intervention: strategies that aim to teach the baby to fall asleep independently. by nurses to improve nighttime awakenings and facilitate the onset of sleep, through gradual extinction and follow-up for 60 days.	Usual assistance of maternal and child health nurses	Maternal report of decreased sleep problems	- Psychological, physical and maternal well-being; - Amount and quality of maternal sleep. (form of measurement not mentioned).
A randomized ontrolled trial to compare alternative strategies for preventing infant crying and sleeping problems in the first 3 months of life Country: United Kingdom Year: 2004	(1) Sleep education to intervene in the sleep environment, reinforced feeding at the end of the night, and teaching the baby to sleep in the crib; (2) Sleep education + educational manual + visit by health visitors.	Standard visit by health visitors, offered by the government	Number of nights without awakening per week (between 10 p.m. and 5 a.m.).	Not mentioned

Associação Brasileira de Enfermagem SGA Norte Quadra 603 Conj. "B" - Av. L2 Norte 70830-102 Brasília, DF, Brasil, Tel.: (55 61) 3226-0653, Fax: (55 61) 3225-4473 - Brasília - DF - Brazil
E-mail: reben@abennacional.org.br

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[1] Corresponding author: Rayanne Branco dos Santos Lima E-mail: rayannebranco@gmail.com