Randomized controlled trial of early sleep intervention to improve infant sleep quality

Phase 2

Completed

• Conditions: duration of nighttime sleep and number of night waking in infant aged 4-6 month; infant sleep

• Registration Number: TCTR20230117001
• Lead Sponsor: avamindradhiraj University Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-17
• Study Completion: 2023-01-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

1. infant age 4 months old (+/- 2 week)
2. night waking >/= 3 times/night

Exclusion Criteria

Infants 1. syndromes or genetic diseases
2. major neurological abnormalities : brain anomaly, epilepsy, cerebral palsy, sequences of neuro-involving conditions, Global developmental delay (GDD)
3. history of cow milk protein allergy
4. using of anticonvalsants or sedative drugs more than 1 weeks
5. previous diagnosed with colic
6. Severe birth asphyxia : ICD-10-APGAR at 1 minute, score 0-3 or birth body weight < 2500 gram or birth before 37 week of GA
7. twin of participants

Parents 1. Center for Epidemiological Studies-Depression Scale (CES-D) score > 22 point
2. Not understanding in Thai
3. unknown infant sleep history
4. can not follow up until study finished

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sleep quality (times/duration) 2 months after intervention sleep questionnaire

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A