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Monitoring Growth of Preterm Infants

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ClinicalTrials.gov Identifier: NCT01869153
Recruitment Status : Terminated (Study expired; PI failed to submit study to IRB for continuing review)
First Posted : June 5, 2013
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
Growth is poor in preterm infants, partly due to difficulty identifying when growth is slow. The investigators will examine the use of a computer program to try and identify periods of growth slowing in preterm babies, and compare those results to the usual assessments made on patient care rounds.

Condition or disease
Prematurity

Detailed Description:
We wish to examine the use of a mathematical modeling system to see if it can detect poor growth better (and more quickly) than we can clinically. To do this, we need to know what the clinical team think about a baby's growth day-to-day. However, after rounds the fellow or NNP with fill in a sheet to say what the team thought about the baby's growth (was it okay, too slow, too fast etc.), and whether any changes were made to improve the baby's growth (e.g. increased feed volume, change in composition of feeds etc.). After the baby is discharged home, weight data from the EMR will be entered into the program to try and identify times where growth slowed (or where growth was faster than expected). We will compare the results of the computer program and the record of the clinical teams thoughts on the ward round, to see if the computer program identified growth slowing more quickly than the clinical team did.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Monitoring Growth of Preterm Infants
Study Start Date : May 2013
Actual Primary Completion Date : June 22, 2015
Actual Study Completion Date : July 10, 2018

Group/Cohort
Preterm infants
Preterm infants born at either <32 weeks gestation or < 1750g birth weight



Primary Outcome Measures :
  1. Identification of growth slowing [ Time Frame: Between birth and hospital discharge, an average of 10weeks ]
    At time of hospital discharge retrospectively collected data on daily weights (from the EMR) will be entered in to a computer program, to identify times where weight gain slowed significantly. This will be compared to the clinical assessment of the baby's growth made at the time (and recorded prospectively)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants of gestational age < 32w at birth, or <1750 weight at birth.
Criteria

Inclusion Criteria:

  1. Birth weight < 1750g gestational age < 32w at birth

    Exclusion Criteria:

  2. Currently receiving parenteral nutrition or intravenous lipids

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): NCT01869153


Locations
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United States, California
NICU, University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Ian Griffin, MD University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01869153     History of Changes
Other Study ID Numbers: 308519
UCD-308519 ( Other Identifier: UCDavis )
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Keywords provided by University of California, Davis:
Growth, weight