Post-hospitalization Nursing Effectiveness (PHONE) Study (NCT00314431) | Clinical Trial Compass
CompletedPhase 3
Post-hospitalization Nursing Effectiveness (PHONE) Study
United States150 participantsStarted 1996-05
Plain-language summary
Based on success with telephone follow up for other groups of medically fragile infants, we designed an innovative model of post-hospital comprehensive and coordinated follow-up for infants with chronic lung disease. In this model, which we refer to as community-based follow-up, medical management was coordinated by a nurse specialist, through frequent telephone contacts with the infants' primary caregiver. This model of follow up care was compared, in a randomized trial, with the more traditional model - multidisciplinary medical center-based care. We hypothesized that community-based care would lead to health and developmental outcomes similar to those observed with center-based care.
Who can participate
Age range
1 Day – 483 Days
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:
* Infants were eligible if they were born before 33 weeks gestational age, required supplemental oxygen at 36 weeks gestational age, and were discharged home after neonatal intensive care.
Exclusion Criteria:
* Neonates who had major congenital anomalies and/ or had tracheostomy tubes were excluded. Also excluded were families in which the mother did not speak English, because the intervention depended on verbal communication with the nurse specialist, and families who lived more than 150 miles from our clinic because such families typically are referred to regional neonatal center closer to their home.
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
Bayley Scales of Infant Development-Second Edition