NCT01869153

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2015

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

May 27, 2013

Last Update Submit

September 18, 2018

Conditions

Keywords

Growth, weight

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Preterm infants

Preterm infants born at either \<32 weeks gestation or \< 1750g birth weight

Eligibility Criteria

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

Preterm infants of gestational age \< 32w at birth, or \<1750 weight at birth.

You may qualify if:

  • Birth weight \< 1750g gestational age \< 32w at birth

You may not qualify if:

  • Currently receiving parenteral nutrition or intravenous lipids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NICU, University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Premature BirthBody Weight

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ian Griffin, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2013

First Posted

June 5, 2013

Study Start

May 1, 2013

Primary Completion

June 22, 2015

Study Completion

July 10, 2018

Last Updated

September 20, 2018

Record last verified: 2018-09

Locations