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

NCT ID: NCT05843396

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2030-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Development, Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Neonatal Massage Received

Group Type ACTIVE_COMPARATOR

Neonatal Massage

Intervention Type BEHAVIORAL

caregivers providing therapeutic touch techniques on their neonate

No Massage Received

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neonatal Massage

caregivers providing therapeutic touch techniques on their neonate

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chad Sylvester, MD/PhD

Role: CONTACT

(314) 286-1700

Victoria Brooks

Role: CONTACT

3144970223

Facility Contacts

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Kristina Hufnagle

Role: primary

612-625-5000

Victoria Brooks

Role: primary

314-312-2684

Other Identifiers

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1368060

Identifier Type: -

Identifier Source: org_study_id

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