Evaluation of Methods to Study the Neuroendocrine Mechanisms of Developmental Massage in Preterm Infants - Full Text View

Evaluation of Methods to Study the Neuroendocrine Mechanisms of Developmental Massage in Preterm Infants (PREMA)

This study is currently recruiting participants.

Verified by University of Utah, July 2009

First Received: January 29, 2009 Last Updated: July 6, 2009 History of Changes

Sponsored by:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00833222

Purpose

The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35 weeks post-menstrual age (PMA)] premature infants.

Condition
Premature Birth

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Methods to Study the Neuroendocrine Mechanisms of Developmental Massage in Preterm Infants

Further study details as provided by University of Utah:

Primary Outcome Measures:

Growth trajectory [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole Blood; Saliva

Estimated Enrollment:	40
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Detailed Description:

To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth.
To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin.
To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements and of the DMT treatment.
To develop a MOP for our future study of neuroendocrine mechanisms of DMT in premature infants.

Eligibility

Ages Eligible for Study:	32 Weeks to 35 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Premature infants admitted to the University of Utah Newborn Intensive Care Unit

Criteria

Inclusion Criteria:

Infants born between 32 4/7 and 35 3/7 weeks gestation by physical exam at birth
Birth weight between the 10th and 90th percentile corrected for gestational age

Exclusion Criteria:

Chromosomal abnormalities
Major congenital anomalies
Major surgery
Severe CNS injury
Inborn errors of metabolism
Assisted ventilation
Inability to start enteral feeds by 96 hours of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833222

Contacts

Contact: Hillarie Slater	801/585-6227	Hillarie.Slater@hsc.utah.edu
Contact: Laurie Moyer-Mileur	801/587-7488	Laurie.Moyer-Mileur@hsc.utah.edu

Locations

United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Hillarie Slater 801-585-6227 Hillarie.Slater@hsc.utah.edu
Principal Investigator: Laurie Moyer-Mileur, PhD

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Laurie Moyer-Mileur, PhD

University of Utah

More Information

No publications provided

Responsible Party:	University of Utah ( Laurie Moyer-Mileur )
Study ID Numbers:	24087
Study First Received:	January 29, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00833222 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

premature birth

Study placed in the following topic categories:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

Additional relevant MeSH terms:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on August 28, 2009