NCT02083952

Brief Summary

Gastroesophageal reflux disease (GERD) has been reported in up to 85% of all infants born prematurely, and has been associated with a wide range of symptoms. These include irritability, pauses in breathing, heart rate drops, declines in oxygen levels, chronic lung disease, and delays in growth and development. A novel approach to the mangement of GERD in infants is the use of an abdominal band, applying gentle pressure and possibly reducing the reflux of acid from the stomach. The purpose of this study is to evaluate the impact of a swaddle blanket with an abdominal band insert on the incidence of infant apnea, bradycardia, oxygen declines, and pH (acid) changes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

1.8 years

First QC Date

March 4, 2014

Last Update Submit

January 19, 2015

Conditions

Gastroesophageal RefluxApneaBradycardiaOxygen Desaturations

Outcome Measures

Primary Outcomes (1)

  • pH

    all epochs of pH values below 4.0 will be measured

    24 hours

Secondary Outcomes (1)

  • apnea

    24 hours

Other Outcomes (2)

  • bradycardia

    24 hours

  • oxygen desaturations

    24 hours

Study Arms (1)

swaddle blanket

EXPERIMENTAL
Other: Swaddle Blanket

Interventions

Swaddle BlanketOTHER

Two arms involve varying time spent in blanket

swaddle blanket

Eligibility Criteria

Age2 Days - 180 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- NICU patients who have a 5 channel study requested by the attending neonatologist -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal RefluxApneaBradycardia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Officials

  • Mary T Carbone, MD

    The Valley Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary T Carbone, MD

CONTACT

201-447-8152

Margaret Bischoff, MSN

CONTACT

201-447-8746mbischo@valleyhealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 11, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

US(1)