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Single patient room for Neurodevelopmental Outcomes

Q: How many candidates are being accepted into this trial's cohort?

<p>Affirmative. Clinicaltrials.gov has information verifying that this clinical trial, initially posted on April 11th 2018, is actively looking for participants to join their experiment. A total of 160 individuals are required from a single research centre.</p>

Q: Are recruitment efforts underway for this scientific experiment?

<p>Affirmative, the clinical trial is currently enrolling patients according to information posted on clinicaltrials.gov. This study was first launched in April of 2018 and updated most recently in March of 2019. 160 participants are sought from one location.</p>

N/A

Waitlist Available

Led By Michael Vincer

Research Sponsored by IWK Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to age 36 months corrected age

Awards & highlights

Study Summary

This trial will compare the long-term outcomes of infants in an open-bay NICU unit to those in a single-patient room unit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to age 36 months corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to age 36 months corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to age 36 months corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with neurodevelopmental impairment or death

Secondary outcome measures

Number of Participants with cerebral palsy

Number of Participants with low cognitive scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)

Number of Participants with low language scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Single Patient RoomExperimental Treatment1 Intervention

Patients randomized to this arm will be admitted to a NICU single patient room.

Group II: Open BayPlacebo Group1 Intervention

Patients randomized to this arm will be admitted to the open bay NICU Unit.

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Find a Location

Who is running the clinical trial?

IWK Health CentreLead Sponsor

125 Previous Clinical Trials

100,313 Total Patients Enrolled

Dalhousie UniversityOTHER

167 Previous Clinical Trials

402,978 Total Patients Enrolled

1 Trials studying Neurodevelopmental Outcomes

1,200 Patients Enrolled for Neurodevelopmental Outcomes

Michael VincerPrincipal InvestigatorDalhousie University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many candidates are being accepted into this trial's cohort?

"Affirmative. Clinicaltrials.gov has information verifying that this clinical trial, initially posted on April 11th 2018, is actively looking for participants to join their experiment. A total of 160 individuals are required from a single research centre."

Answered by AI

Are recruitment efforts underway for this scientific experiment?

"Affirmative, the clinical trial is currently enrolling patients according to information posted on clinicaltrials.gov. This study was first launched in April of 2018 and updated most recently in March of 2019. 160 participants are sought from one location."

Answered by AI

Recent research and studies

Journal of PerinatologyJournal

Documenting the NICU Design Dilemma: Comparative Patient Progress in Open-ward and Single Family Room Units

Domanico, R, D K Davis, F Coleman, and B O Davis. 2010. “Documenting the NICU Design Dilemma: Comparative Patient Progress in Open-ward and Single Family Room Units”. Journal of Perinatology. Springer Science and Business Media LLC. doi:10.1038/jp.2010.120.

Developmental Medicine & Child NeurologyJournal

Development and Reliability of a System to Classify Gross Motor Function in Children with Cerebral Palsy

Palisano, Robert, Peter Rosenbaum, Stephen Walter, Dianne Russell, Ellen Wood, and Barbara Galuppi. 2008. “Development and Reliability of a System to Classify Gross Motor Function in Children with Cerebral Palsy”. Developmental Medicine & Child Neurology. Wiley. doi:10.1111/j.1469-8749.1997.tb07414.x.

American Journal of PerinatologyJournal

Does Individual Room Implemented Family-centered Care Contribute to Mother–infant Interaction in Preterm Deliveries Necessitating Neonatal Intensive Care Unit Hospitalization?

Erdeve, Omer, Saadet Arsan, F. Canpolat, Ilgi Ertem, Belma Karagol, Begum Atasay, Murat Yurdakok, Gulsevin Tekinalp, and Tomris Turmen. 2008. “Does Individual Room Implemented Family-centered Care Contribute to Mother–infant Interaction in Preterm Deliveries Necessitating Neonatal Intensive Care Unit Hospitalization?”. American Journal of Perinatology. Georg Thieme Verlag KG. doi:10.1055/s-0028-1095186.

The Journal of PediatricsJournal