CompletedNot Applicable

Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy

United States130 participantsStarted 2017-06-09

Plain-language summary

The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition suck-strength and rhythmicity, in improving the feeding and developmental outcomes of infants at high-risk for CP.

Who can participate

Age range

32 Weeks – 12 Months

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: * PMA at enrollment \>32 6/7 and \<42 AND * Diagnoses of Grade III/IV IVH, hydrocephalus or PVL, neonatal encephalopathy or thrombosis/infarct with involvement of the posterior limb of the internal capsule OR * Abnormal GMA by certified study staff and masked gold-standard reading Exclusion Criteria: Infants cannot be * on assisted ventilation * receiving more than 50% of their feeds orally averaged over the 72 hours prior to study start * receiving less than 50% of their feeds enterally * receiving enteral feed for greater than 60 min. * considered medically unsafe to feed orally by the medical or feeding team as defined by unit/clinical protocol

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

Oral Feeding Efficiency

Timeframe: Twelve months

Trial details

NCT IDNCT03230032

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-31

View on ClinicalTrials.gov More Infant Development trials

Who can participate

Age range

32 Weeks – 12 Months

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.