NCT01643057

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

July 13, 2012

Last Update Submit

September 9, 2015

Conditions

Apnea of Prematurity

Keywords

ApneaPrematurityBiomarkersStochastic ResonanceNeonatal

Outcome Measures

Primary Outcomes (1)

  • Investigate effects of mattress intervention on breathing patterns

    Focus on inter-breath intervals and oxygen desaturation.

    Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.

Secondary Outcomes (1)

  • Candidate Biomarkers for Apnea of Prematurity

    Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.

Study Arms (1)

Stochastic Resonance Mattress

The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available, designed by engineers at the Wyss Institute, Harvard University) to provide gentle vibrations and sounds during mattress stimulations.

Device: Stochastic Resonance Mattress

Interventions

Stochastic Resonance MattressDEVICE

The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available, designed by engineers at the Wyss Institute, Harvard University) to provide gentle vibrations and sounds during mattress stimulations.

Stochastic Resonance Mattress

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infants currently inpatient in the Neonatal Intensive Care Unit at Beth Israel Deaconess Medical Center.

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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Smith VC, Kelty-Stephen D, Qureshi Ahmad M, Mao W, Cakert K, Osborne J, Paydarfar D. Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial. Pediatrics. 2015 Dec;136(6):e1561-8. doi: 10.1542/peds.2015-1334.

    PMID: 26598451DERIVED

MeSH Terms

Conditions

ApneaPremature Birth

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Vincent C Smith, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

  • David Paydarfar, MD

    UMASS Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 17, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

US(1)