CompletedNot Applicable

Therapist Education and Massage for Parent Infant-Outcomes

United States68 participantsStarted 2019-11-25

Plain-language summary

The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant behavioral-motor development, principles of family-centered care, and multiple modes of educational delivery to enhance parent retention of knowledge, parent-infant bonding, and confidence in continuing physical therapy interventions after discharge.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants with gestational age \<28 weeks gestation, within the first 3 weeks of life, and their * Biologic mother or father must be able to speak and understand English. Exclusion Criteria: * Infants who do not have a biological parent available to consent within the first 3 weeks of life. * Infants with genetic/chromosomal abnormality, congenital neurological or musculoskeletal disorder, or abnormal bone density related to a congenital condition that would affect the ability to do massage and/or exercise and the safety of the infant. * Parents who are unwilling to engage in all components of TEMPO.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment)

Timeframe: Baseline

Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants

Timeframe: Final follow up visit - an average of 15-18 months after study period begins

Percent of Parents Who Complete All Protocol Components (Adherence)

Timeframe: At hospital discharge, approximately 8-16 weeks after enrollment

Percent of Parents Who Are Retained in the Study at 12 Months (Retention)

Timeframe: Final follow up visit - an average of 15-18 months after study period begins

Percent of Enrolled Parents Who Provide Complete Data and Interviews

Timeframe: Final follow up visit - an average of 15-18 months after study period begins

Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities

Timeframe: at First follow up visit - approximately 1 to 2 months after hospital discharge

Trial details

NCT IDNCT04121897

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-01

Results submitted2023-02-09

View on ClinicalTrials.gov More Parent-Child Relations trials