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Behavioural Intervention

Intervention for Massage Therapy

N/A

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gestational age greater than 23 6/7 weeks and less than 32 weeks at birth

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour before intervention and up to 3 hours post-intervention

Awards & highlights

Study Summary

This trial will study the effects of Neonatal Touch and Massage Therapy on premature babies, to see if it reduces NICU stay, improves weight gain and neurodevelopment.

Who is the study for?

This trial is for premature babies born between 23 and almost 32 weeks, who are medically stable and in the University of Maryland NICU within their first two weeks. Babies with life-threatening conditions, heart issues, those needing major surgery or critically ill at intervention time, or with certain bone problems can't join.Check my eligibility

What is being tested?

Researchers are testing if Neonatal Touch and Massage Therapy helps premature babies leave the NICU sooner compared to standard care. They're looking at weight gain, pain/stress response, and brain development outcomes.See study design

What are the potential side effects?

Since this therapy involves gentle touch and massage for infants, there may be minimal risk of side effects. However, each infant's tolerance will be closely monitored by medical staff.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby was born between 24 and 31 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour before intervention and up to 3 hours post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour before intervention and up to 3 hours post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour before intervention and up to 3 hours post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of stay

Secondary outcome measures

Head growth

Linear growth

Neurodevelopmental Outcomes

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

This group will receive structured neonatal touch or massage therapy from a certified NICU provider. Therapy will given 3 days a week for 5 to 15 minutes for a minimum of 4 weeks. We will also be collecting data to assess pain and stress responses during the period immediately before, during, and shortly after the therapy. This includes assessment of crying/irritability, behavior state, facial expression, extremities tone, and vital signs (heart rate, breathing rate, and oxygen levels).

Group II: ControlActive Control1 Intervention

This group will receive standard NICU care, no different than if they were not enrolled in the study.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,624 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study open to new participants?

"Yes, the trial is currently enrolling volunteers. The original posting date was November 1st 2023 and the last modification to the data took place on November 30th 2023."

Answered by AI

How many participants are currently eligible for inclusion in this clinical trial?

"Affirmative, the information available on clinicaltrials.gov implies that this research is actively searching for participants. Initially posted in November 1st 2023 and modified recently on 30th of the same month, this investigation requires 32 test subjects from one location."

Answered by AI

Does this experiment accept participants aged 30 or older?

"For this particular trial, the age requirements are between 24 Weeks and 32 Weeks. Additionally, there are 187 trials for minors and 83 for those who have reached seniority."

Answered by AI

To whom is participation in this experiment open?

"To qualify for this clinical study, individuals must have been born prematurely and be between 24 to 32 Weeks. Furthermore, no more than 32 participants will be accepted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Infant Massage in the NICU

Johana Diaz 2023. "Infant Massage in the NICU". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06163586.