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Infant, Premature DevelopmentNCT00179985

The Impact of Implementing NIDCAP on the Developmental Sensitivity of Nurses Caring for Preterm Infants

An observational study of Infant, Premature Development, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Infant, Premature Development
How many people
32 participants
Where
1 siteUnited States
Study dates
Dec 2004to Jul 2011
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: NICU Nurse

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Neonatal Intensive Care Unit, Children's Memorial Hospital

    Chicago, Illinois, 60148

Other trials in United States

About this study

Official title: The Impact of Implementing The Newborn Individualized Developmental Care & Assessment Program on the Developmental Sensitivity of Nurses Caring for Preterm Infants

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.

Read the detailed description

Therapies that have brought about sharp decreases in neonatal mortality have not brought about similar decreases in neurodevelopmental morbidity for preterm infants. Developmentally supportive care is NICU (Neonatal Intensive Care Unit) care that seeks to optimize the developmental course and outcomes for preterm infants. In controlled trials, implementation of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) has been associated with with positive medical and neurobehavioral outcomes. The purpose of this study is to examine the impact of implementing the NIDCAP on the developmental sensitivity of nurses caring for preterm infants in a tertiary level NICU in a children's hospital in the midwest. The NIDCAP program consists of 1) structured behavioral observations which are conducted at regular intervals during the preterm infant's hospitalization, 2) written plans which outline specific, individualized interventions to address the infant's unique developmental needs which are updated following each observation, and 3) consultations with the infant's caregivers to articulate the infant's current needs and plan. A convenience sample of 32 NICU nurses will be observed during a routine caregiving episode with one preterm infant before and another preterm infant after the implementation of the NIDCAP program with preterm infants in the NICU. Following the observations, the nurse's developmental sensitivity will be scored using a standardized tool. The nurses' developmental sensitivity before the implementation of the NIDCAP program will be compared with their developmental sensitivity following NIDCAP implementation. Informed consent will be obtained from the nurses participating in the study.

Keywords
Developmental Care, Neonatal Intensive Care Unit (NICU)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00179985
Study groupRoleWhat they receive
TrainingBehavioral: Newborn Individualized Care and Assessment Program (NIDCAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionMay 2006
  4. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00179985
Sponsor's protocol ID
IRB#2005-12423
Status last verified
Jul 2011
First submitted
14 Sep 2005
Last updated
29 Jul 2011
Results posted
No
Data monitoring committee
Yes

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