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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230117001
Enrollment
346
Registered
2023-01-17
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

duration of nighttime sleep and number of night waking in infant aged 4-6 month infant sleep

Interventions

Parental knownledge about normal development of sleep, sleep hygeine and management
Experimental Behavioral
early sleep intervention

Sponsors

Navamindradhiraj University Research Fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Weeks to 18 Weeks

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
sleep quality (times/duration) 2 months after intervention sleep questionnaire

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactDussadee Ngernlangtawee

Navamindradriraj university

dussadee.n@nmu.ac.th0812504144

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026