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The effects of multisensory stimulation bundles on sleep and neurobehavioral development during first year after birth in very preterm infants: A randomized crossover-controlled study protocol

The effects of multisensory stimulation bundles on sleep and early neurobehavioral development in very preterm infants: A randomized crossover-controlled study protocol

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059099
Enrollment
Unknown
Registered
2022-04-25
Start date
2022-04-14
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

Premature

Interventions

Group A:Standard care plus multisensory stimulation bundles for 2 weeks after allocation
standard care for the next 2 weeks
Group B:Standard care for 2 weeks after allocation
standard care plus multisensory stimulation bundles for the next 2 weeks

Sponsors

Shanghai Children's Medical Center, Shanghai Jiangtong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants who are clinically stable in a NICU born at a minimum of 28 weeks GA and less than 32 weeks GA; 2. Birth weight between the 10th and 90th percentiles of the average birth weight for the same gestational age, identified as appropriate for gestational age (WHO, 2012); 3. Parents agreed to study participation as well as follow-up diagnosis and treatment at our hospital within the following year.

Exclusion criteria

Exclusion criteria: 1. Congenital malformation in the infant that interferes with the intervention or for which the intervention interferes with the required care (e.g., complex congenital heart disease, complex gastrointestinal malformations, diaphragmatic hernia); 2. Severe nervous system malformations or disorders (e.g., bilirubin encephalopathy, central nervous system infection, intracranial hemorrhage of >=degree III); 3. Independent predictors of disturbed sleep or neurodevelopment (e.g., inborn metabolism errors, preeclampsia, bronchopulmonary dysplasia) and family with low socioeconomic status; 4. Visual or hearing impairment.

Design outcomes

Primary

MeasureTime frame
Sleep;

Secondary

MeasureTime frame
Burdjalov score;Griffiths Mental Development Scales (GMDS);

Countries

China

Contacts

Public ContactXiaoli Tang

Shanghai Children's Medical Center, Shanghai Jiangtong University School of Medicine

tangxiaoli@scmc.com.cn+86 18930871509

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026