Monitoring Growth of Preterm Infants

Prematurity Clinical Trial

Official title:

Monitoring Growth of Preterm Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01869153
• Other study ID #: 308519
• Secondary ID: UCD-308519
• Status: Terminated
• Start date: May 2013
• Est. completion date: July 10, 2018

Study information

• Verified date: September 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: July 10, 2018
• Est. primary completion date: June 22, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

2. Currently receiving parenteral nutrition or intravenous lipids

Related Conditions & MeSH terms

• Prematurity

Locations

Country	Name	City	State
United States	NICU, University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of growth slowing	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)	Between birth and hospital discharge, an average of 10weeks