Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Reading to Preterm Infants on Baby and Parents' Well Being

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518997
Recruitment Status : Completed
First Posted : August 10, 2015
Results First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Melissa Scala, Georgetown University

Brief Summary:
Reading to children is believed to be beneficial to cognitive and mental development.This study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen levels. The investigators will follow rates of common preterm health issues while in the hospital and time to hospital discharge. Effects of bedside reading on parental stress and infant bonding will be measured and compared to usual rates of these indicators to determine if reading to babies reduces stress and enhances bonding.

Condition or disease Intervention/treatment Phase
Parental Infant Bonding Cardio-respiratory Stability in Preterm NICU Infants Other: Parental Reading Aloud Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Reading to Preterm Infants on Baby and Parents' Well Being
Study Start Date : October 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: All enrolled infants
All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability.
Other: Parental Reading Aloud
Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring.




Primary Outcome Measures :
  1. Percent of Oxygen Saturation Measurements <85% [ Time Frame: While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks ]
    Percent of measured oxygen saturations recorded as less than 85%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants between 26 0/7 34 6/7 weeks corrected gestational age (CGA) at the time of enrollment, [gestational age stated as # of weeks plus the number of days of the next week completed, the days are expressed as a fraction of a 7 day week (CGA= GA at birth + days of life)] rationale: 26 0/7 is the age at which the auditory system is generally well formed but still immature. Infants born at less than 26 0/7 weeks GA can be enrolled once they reach 26 0/7 weeks.
  2. Infants at least 7 days of life to allow for transition to extrauterine life.

Parental Inclusion Criteria

  1. Agreement to the study with signed Informed Consent Form and HIPAA Authorization
  2. Visits on a regular basis (at least 3 times per week)
  3. Is literate (able to read)

Exclusion Criteria:

  1. Infants deemed too ill to participate by the primary care team at one week of age, although those infants may be enrolled at a later date when they are stabilized with the approval of the clinical care team,
  2. infants with congenital hearing loss,
  3. chromosomal abnormalities,
  4. infants not expected to survive.

Parents Exclusions Does not read or is uncomfortable reading aloud. (unlikely to sign informed consent if this is the case)

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518997


Locations
Layout table for location information
United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Layout table for investigator information
Principal Investigator: Melissa L Scala, MD Georgetown University
  Study Documents (Full-Text)

Documents provided by Melissa Scala, Georgetown University:
Layout table for additonal information
Responsible Party: Melissa Scala, Assistant Professor of Pediatrics, Georgetown University
ClinicalTrials.gov Identifier: NCT02518997    
Other Study ID Numbers: 2014-1464
First Posted: August 10, 2015    Key Record Dates
Results First Posted: January 28, 2020
Last Update Posted: January 28, 2020
Last Verified: January 2020
Keywords provided by Melissa Scala, Georgetown University:
Preterm Infants
Bedside Reading aloud
Parental wellbeing
Parental Bonding
cardio-respiratory stability
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications