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Overview of clinical trial protocols for behavioral insomnia in infants

Rayanne Branco Dos Santos Lima1, Ana Jéssica Lopes Dias1, Lorena Pinheiro Barbosa1

  • 1Universidade Federal do Ceará. Fortaleza, Ceará, Brazil.

Revista Brasileira De Enfermagem
|June 30, 2021
PubMed

Insights

This study reviewed clinical trials for infant behavioral insomnia, finding interventions focused on independent sleep. The goal was to improve sleep for both infants and their families.

Area of Science:

  • Pediatrics
  • Sleep Medicine
  • Behavioral Science

Background:

  • Infant behavioral insomnia is a common issue affecting families.
  • Understanding current clinical trial approaches is crucial for developing effective interventions.

Purpose of the Study:

  • To provide an overview of clinical trial protocols for infant behavioral insomnia.
  • To identify interventions, comparators, outcomes, and measurement tools used in registered trials.

Main Methods:

  • An analytical study reviewed protocols registered on the International Clinical Trials Registry Platform.
  • Protocols were screened for relevance to infant behavioral insomnia.
  • Data on interventions, outcomes, and measurements were extracted.

Main Results:

  • Eleven protocols registered between 2004 and 2018 were analyzed.
  • Nurses predominantly coordinated trials (45.5%).
  • Interventions included educational technologies, one-to-one, and online consultations, focusing on infant and maternal sleep patterns, anxiety, depression, and parental sexual satisfaction.

Conclusions:

  • Clinical trial protocols for infant behavioral insomnia primarily aim to promote independent sleep.
  • Interventions are designed to enhance sleep quality for the entire family.
  • Standardized outcome measures like sleep diaries and actigraphy are frequently employed.
Abstract

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