Examining parental stress and care needs for infants at high risk of developmental delay after NICU discharge
Study of Parental Stress and Care Consumption Until 24 Months Corrected Age of Infants at a High Risk of Developmental Delay, After Discharge From Neonatal Intensive Care
This study is trying to understand how much stress parents feel and what care their high-risk infants need after leaving the NICU to help improve support for families.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05233371 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the impact of parental stress and healthcare consumption for infants at high risk of developing cerebral palsy after being discharged from the neonatal intensive care unit (NICU). It aims to identify high-risk infants and ensure continuous follow-up care, emphasizing early intervention before 6 months of corrected age. The study will utilize the Parenting Stress Index (PSI) to assess parental stress levels, collect data on healthcare consumption, and evaluate parent satisfaction with the care provided. The findings could inform better management strategies for these vulnerable infants and their families.
Who should consider this trial
Good fit: Ideal candidates include parents of infants hospitalized in the neonatal unit who meet specific risk criteria, such as prematurity or significant neonatal complications.
Not a fit: Patients who may not benefit include those whose infants have major orthopedic or traumatic disorders unrelated to neurodevelopmental risks.
Why it matters
Potential benefit: If successful, this study could lead to improved early interventions and support for families of infants at risk of cerebral palsy, enhancing developmental outcomes.
How similar studies have performed: Other studies have shown success in early identification and intervention for high-risk infants, supporting the potential effectiveness of this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parents of children hospitalized in the neonatal unit of the CHU Dijon and meeting at least one of the criteria below: * Premature infants ≤ 31 weeks amenorrhea + 6 days * And/or birthweight less than 1500 g, * And/or children who presented with Intra-Ventricular Hemorrhage stages 3 or 4 according to the classification of Volpe et al. or Papile et al, * And/or children who have had a cerebral vascular accident or anoxic-ischemic encephalopathy stage 2 or 3 according to the Sarnat classification, * And/or children who have had a so-called serious condition during the neonatal period (i.e. cardiac or visceral surgery). Exclusion Criteria: * Parents who are minors, * Parents under court protection, * Parents of children with major orthopedic or traumatic disorders unrelated to neurodevelopmental risk, * Parents unable to understand and respond to the questionnaires to be completed.
Where this trial is running
Dijon
- CHU Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Sébastien KRUMM
- Email: sebastien.krumm@chu-dijon.fr
- Phone: 03 80 29 30 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.