Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health

Completed

Conditions studied: Apnea of Prematurity

In brief

The purpose of this study is to explore physiological interventions and biomarkers for Apnea of Prematurity in newborn infants.

Key facts

Study ID

NCT01643057

Run by

Wyss Institute at Harvard University

People needed

36

Starts

2012-07-01

Expected to finish

2014-07-01

Last updated by the study team

2015-09-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible subjects are infants currently inpatient in the NICU at Beth Israel Deaconess Medical Center and:
• Born premature, at a gestational age < 36 weeks
• Demonstrate irregular breathing by having had at least one documented clinical apnea (> 20 seconds), bradycardia (< 100 bpm) and/or desaturation (< 90%)

You may not qualify if…

• Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:
• Is at a Post Conceptual Age of > 45 weeks at time of study (Calculated as: weeks of age at birth + weeks of age since birth)
• Has demonstrable pulmonary disease at time of study, i.e. Chronic Lung Disease, Infant Respiratory Distress Syndrome
• Has Hypoxic-Ischemic Encephalopathy including a cord pH of ≤ 7
• Has a congenital abnormality
• Has a genetic syndrome
• Has an anatomic brain anomaly
• Has hydrocephalus or intraventricular hemorrhage > Grade 3 or 4
• Is anemic (hemoglobin < 8g/dL)
• Has an infection at time of study
• Is undergoing therapeutic hypothermia

Where it is running

• Beth Israel Deaconness Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.