The Developmental Effects of NICU Positioning

NCT01628510 | Completed Results DMC

• 1 other identifier: 201111170
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Premature Birth of Newborn

Keywords

preterm

Outcome Measures

Primary Outcomes (1)

• NICU Network Neurobehavioral Scale (NNNS)

  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.

  35 to 41 weeks (term equivalent); prior to NICU discharge

Secondary Outcomes (1)

• The Bayley Scales of Infant Development-3rd Edition (BSID-III)

  1 year, 2 years

Study Arms (2)

Traditional NICU Positioning

ACTIVE COMPARATOR

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

Dandle Roo/Dandle Wrap

EXPERIMENTAL

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

Interventions

Dandle Roo/Dandle Wrap DEVICE

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.

Also known as: Dandle Roo; Dandle Wrap

Dandle Roo/Dandle Wrap

Traditional NICU Positioning OTHER

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®

Also known as: Snuggly®, Bendy Bumper®

Traditional NICU Positioning

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature infants born at or before 32 weeks gestation

You may not qualify if:

• Congenital Anomaly

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Barnes Special Care Nursery

St Louis, Missouri, 63110, United States

Location

St Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Roberta Pineda
• Organization: Washington University

pineda_r@kids.wustl.edu

314-286-1304

Study Officials

• Roberta G Pineda, PhD OTR/L

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 26, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2014
• Last Updated: February 27, 2018
• Results First Posted: April 13, 2015

Record last verified: 2018-01

Locations

US (2)