NCT00179985

Brief Summary

The purpose of this study is to determine whether implementing the Newborn Individualized Developmental Care and Assessment Program increases NICU nurses' sensitivity in meeting the developmental care needs of preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

Enrollment Period

1.4 years

First QC Date

September 14, 2005

Last Update Submit

July 28, 2011

Conditions

Infant, Premature Development

Keywords

Developmental CareNeonatal Intensive Care Unit (NICU)

Outcome Measures

Primary Outcomes (1)

  • Pre-NIDCAP implementation and post-NIDCAP implementation, score on a tool designed to measure NICU nurses' developmental sensitivity.

    Measure NICU nurses' developmental sensitivity after training program

    Two years

Study Arms (1)

Training

Behavioral: Newborn Individualized Care and Assessment Program (NIDCAP)

Eligibility Criteria

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

NICU Nurse

You may qualify if:

  • be an RN,
  • be an employee of the NICU at the study site,
  • have completed the NICU nursing orientation at the study site,
  • work at least 0.4 FTE in the NICU at the study site, and
  • be observed while caring for a preterm infant born at less than or equal to 36 weeks gestation and at less than or equal to 1500 grams

You may not qualify if:

  • Nurses will not be observed while caring for fullterm infants or preterm infants receiving heavy sedation or paralyzing medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit, Children's Memorial Hospital

Chicago, Illinois, 60148, United States

Location

Study Officials

  • Susan M Horner, RNC, MS

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

December 1, 2004

Primary Completion

May 1, 2006

Study Completion

July 1, 2011

Last Updated

July 29, 2011

Record last verified: 2011-07

Locations

US(1)