Early Intervention in Preterm Infants: Short and Long Term Developmental Outcome After a Parental… (NCT02983513) | Clinical Trial Compass
CompletedNot Applicable
Early Intervention in Preterm Infants: Short and Long Term Developmental Outcome After a Parental Training Program
Italy70 participantsStarted 2014-04
Plain-language summary
Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period of stressful environment, which may negatively impact early brain development and subsequent neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in reducing stressful experiences early in life and in enhancing brain development and long term developmental outcomes.
Who can participate
Age range
25 Weeks – 29 Weeks
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:
* Gestational age between 25+0 and 29+6 weeks
Exclusion Criteria:
* major brain lesions as documented by cranial ultrasound (intraventricular hemorrhage \> 2 grade, cystic periventricular leukomalacia)
* neurosensorial deficits (retinopathy of prematurity \> stage 2)
* genetic syndromes and/or major congenital malformations
* major neonatal comorbidities
Mothers are selected according to the following inclusion criteria: age over 18 years, good comprehension of Italian language, no obvious cognitive impairments or psychiatric disorders, no drug addiction and no single-parent families.
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
1
Neonatal Visual Assessment Battery to evaluate visual function
Timeframe: 40 weeks postmenstrual age
2
Neonatal Behavior
Timeframe: 2 months corrected age
Trial details
NCT IDNCT02983513
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico