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The Developmental Effects of NICU Positioning

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628510
First Posted: June 26, 2012
Last Update Posted: September 13, 2017
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.
Information provided by (Responsible Party):
Roberta Pineda, Washington University School of Medicine
  Purpose
The purpose of this study is to investigate the developmental effects of two different types of positioning used with premature infants in the neonatal intensive care unit.

Condition Intervention
Premature Birth of Newborn Device: Dandle Roo/Dandle Wrap Other: Traditional NICU Positioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Investigating the Developmental Effects of Two Different Methods of Neonatal Positioning in the NICU

Further study details as provided by Roberta Pineda, Washington University School of Medicine:

Primary Outcome Measures:
  • NICU Network Neurobehavioral Scale (NNNS) [ Time Frame: 35 to 41 weeks (term equivalent); prior to NICU discharge ]
    The NNNS wasl used to assess neurobehavioral outcome near term equivalent (between 35 weeks and 41 weeks postmenstrual age). This tool consists of eliciting neonatal reflexes and observing behavior. From the assessment, 13 summary scores were determined for each of the following constructs: habituation (1-9), orientation (1-9), self regulation (1-9), tolerance of handling (0-1), hypertonia (0-10), hypotonia (0-10), asymmetry (0-16), lethargy (0-15), excitability (0-15), sub-optimal reflexes (0-15), arousal (1-9), quality of movement (1-9) and stress (0-1). Each summary score is analyzed for associations with subsequent developmental outcome. A higher score in each category indicates more of that construct. Specifically, for the summary score of asymmetry (the significant finding in this study), higher scores equal more asymmetry.


Secondary Outcome Measures:
  • The Bayley Scales of Infant Development-3rd Edition (BSID-III) [ Time Frame: 6 months, 1 year, 2 years and 3 years ]
    The BSID-III is the gold standard for assessing developmental outcome in childhood. Domain scores for language, motor and cognition will be determined.


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: December 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional NICU Positioning
Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
Other: Traditional NICU Positioning
These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper®
Other Names:
  • Snuggly®
  • Bendy Bumper®
Experimental: Dandle Roo/Dandle Wrap
The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
Device: Dandle Roo/Dandle Wrap
Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when the infant is lying in the isolette or crib, but is taken out for hands on care times or when held.
Other Name: Dandle Roo; Dandle Wrap

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion:

  • Premature infants born at or before 32 weeks gestation

Exclusion Criteria:

  • Congenital Anomaly
  Contacts and Locations
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): NCT01628510


Locations
United States, Missouri
Barnes Special Care Nursery
Saint Louis, Missouri, United States, 63110
St Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Roberta G Pineda, PhD OTR/L Washington University School of Medicine
  More Information

Responsible Party: Roberta Pineda, Research Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01628510     History of Changes
Other Study ID Numbers: 201111170
First Submitted: June 19, 2012
First Posted: June 26, 2012
Results First Submitted: December 17, 2013
Results First Posted: April 13, 2015
Last Update Posted: September 13, 2017
Last Verified: August 2017

Keywords provided by Roberta Pineda, Washington University School of Medicine:
preterm

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications


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