CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Baby Play Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04266717
NCT04266717N/ACompleted

A Novel Parent Education Program for Early Intervention

University of Delaware·interventional·Posted Feb 12, 2020·Updated Sep 21, 2023

In Brief

A clinical study evaluating Baby Play Intervention and Milestone Education for Preterm Infant and Full-term Infant. Completed, enrolled 20 participants across 1 site.

Detailed Summary

One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. Because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive early intervention until they are older and their delays are more pronounced. This project aims to address the need for an effective, affordable, novel early intervention model for the first months of life for preterm infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 12, 2020
Enrollment StartJan 17, 2018
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.4 years ago

Interventions

Baby Play Interventionbehavioral

Baby Play Intervention involves teaching parents targeted ways they can handle, position, and play with young infants that aim to provide infants enhanced early opportunities to learn to control their bodies and interact with objects. These abilities are associated with future motor, cognitive, and language outcomes. Parents will be asked to perform the intervention activities 20 minutes daily and to log their activity performance weekly.

Milestone Educationbehavioral

Parents in the Milestone Education Intervention group will receive information regarding milestones expected based on infants' CA. This information is based on forms from the Centers for Disease Control and Prevention (CDC) and The American Academy of Pediatrics (AAP). This will help parents understand the milestones typically observed at the their child's CA and reflects the education parents receive from healthcare providers. Parents will be asked to provide their infants opportunities to perform these milestone behaviors 20 minutes daily and to log their activity performance weekly.