Parents+: An Early Behavioral Intervention as a Pathway for Parent-Partnered Care.
Rosemary White-Traut, Karen Gralton, Marin Schmitt...
https://pubmed.ncbi.nlm.nih.gov/41020674Actively Recruiting
Phase Not Applicable
Age: 1Week - 8Weeks
All Genders
ID07372898
Impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) Intervention on Infants With Congenital Defects Requiring Neonatal Surgery and Their Parents
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2026-01-28
40
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) intervention compared to standard ICU care for infants born with congenital defects requiring major neonatal surgery and their parents. This study focuses on improving early feeding, growth, neurodevelopment, parental mental health, and parent-infant interactions. It addresses the challenges faced by these infants and parents, including risks of neurodevelopmental impairments and adverse mental health outcomes caused by hospitalization and stress exposures. The study involves randomly assigning 40 infants and their parents to either the H-HOPE intervention or standard ICU care. The H-HOPE intervention includes two parts: Parents+ training for parents to learn infant behavioral cues and the Massage+ behavioral intervention, which parents provide twice daily. Massage+ involves talking, massaging, and providing visual and vestibular stimulation adapted to infant tolerance. Control group infants receive usual ICU care and parents are offered an infant care class unrelated to the study. Trained staff may provide Massage+ when parents are unavailable. Participants will be involved from enrollment when the infant is stable and on minimal respiratory support, continuing intervention for around 4 weeks until ICU discharge, with follow-up assessments at 3-4 months post-menstrual age. Researchers will measure infant feeding behaviors, oral feeding progression, growth, neuroendocrine function, motor and neurodevelopment outcomes, as well as parental mental health, cortisol levels, and parent-infant interactions. Safety and adherence will be monitored daily through logs documenting intervention frequency, infant tolerance, and parent presence.
CONDITIONS
Brief Title
Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)
Who Can Participate
Age: 1Week - 8Weeks
All Genders
Eligibility Criteria
You may qualify if you...
- Infants born with a congenital defect requiring major neonatal surgery, including congenital heart disease
- Infants younger than 48 weeks post-menstrual age at H-HOPE start
- Infants clinically stable with no vital sign instability during routine nursing care
- Infants on respiratory support less than a nasal cannula at 2 liters per minute
- Infants off all intravenous pain medications at intervention initiation
- Participation of one or both parents of the infant
You will not qualify if you...
- Infants born before 34 weeks gestation
- Infants with congenital defects involving the nervous system such as spina bifida or congenital hydrocephalus
- Infants with genetic syndromes
- Infants with history of Extracorporeal Membrane Oxygenation
- Infants with mechanical ventilation lasting 30 or more days
- Infants who are wards of the state
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Outpatient Treatment
Duration - Approximately 4 weeks
Participants receive the H-HOPE intervention, which includes Parents+ training and Massage+ sessions administered by parents or trained staff to support infant development and parent-infant interactions. Control participants receive standard ICU care and an infant care class unrelated to the intervention.
Daily parent-administered Massage+ sessions up to 2 times per day
Follow-up
Duration - Up to 3 to 4 months post-menstrual age
Participants are assessed at ICU discharge and again at 3 to 4 months post-menstrual age to evaluate infant neurodevelopment, feeding outcomes at home, parental mental health, and parent-infant interactions.
Visits at ICU discharge and at 3 to 4 months post-discharge
Trial Site Locations
Total: 1 location
1
Ann & Robert H Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
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Research Team
S
Susan Horner, PhD
S
Steven M Ward, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Protocol for implementation of an evidence based parentally administered intervention for preterm infants.
Rosemary White-Traut, Debra Brandon, Karen Kavanaugh...
https://pubmed.ncbi.nlm.nih.gov/33761902