N/A
Completed N=68
Therapist Education and Massage for Parent Infant-Outcomes
Parent-Child Relations · Parents · Extreme Prematurity
Source: ClinicalTrials.gov NCT04121897 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment) — 91 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment) |
91 | — |
| PRIMARY Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants |
100 | — |
| PRIMARY Percent of Parents Who Complete All Protocol Components (Adherence) |
87 | — |
| PRIMARY Percent of Parents Who Are Retained in the Study at 12 Months (Retention) |
56 | — |
| PRIMARY Percent of Enrolled Parents Who Provide Complete Data and Interviews |
56 | — |
| PRIMARY Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities |
4.5 | — |
| PRIMARY Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure |
81; 95; 100; 91 | — |
| PRIMARY Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure |
78; 100; 100; 91 | — |
| PRIMARY Qualitative Summaries of Parent Experience Via Interview |
95; 100; 95 | — |
| SECONDARY Mean Infant Salivary Cortisol Level |
— | — |
| SECONDARY Parent Salivary Cortisol Level |
-18.05 | 0.024 sig |
| SECONDARY Bayley Scales of Infant Development IV |
11.6 | — |
| SECONDARY Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety |
20; 12; 10; 9.5 | — |
| SECONDARY Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale |
15.4; 8.21; 8.0; 7.83 | — |
| SECONDARY Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale |
17.2; 18.36; 18.7; 19.2 | — |
| SECONDARY Longitudinal Measures Changes in Parenting Sense of Competence Scale |
76.6; 82.61; 85.0; 87.2 | — |
| SECONDARY Postnatal Attachment Questionnaire |
87.9 | — |
| SECONDARY Longitudinal Measures in Infant Temperament Using Carey Temperament Scales |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04121897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.