Brain Organization, Development, and Response to Intervention in Individual Neonates

The Washington University

Status: Enrolling

Conditions: Development, Infant

Treatments: Behavioral: Neonatal Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT05843396

1368060

Details and patient eligibility

About

The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.

Enrollment: 80 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• English speaking
• Ability to give informed consent

Exclusion criteria

• Prisoners (vulnerable population)
• Pregnant women <18 years of age
• Active psychosis, mania, suicidal ideation (safety)
• Active substance dependence
• Non-singleton pregnancy (e.g., twins)
• Gestational Age <36 weeks (neonates)
• Neonatal encephalopathy (neonates)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Neonatal Massage Received

Active Comparator group

Treatment:

Behavioral: Neonatal Massage

No Massage Received

No Intervention group