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Weaning Thermoregulatory Support in Preterm Neonates

This study has been terminated.
(insufficient resources to conduct study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00769262
First Posted: October 9, 2008
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Missouri-Columbia
  Purpose
Preterm newborns typically must be thermally regulated. In the United States, isolettes (incubators) are used to help them maintain their temperature. Traditionally, the temperature support (i.e. the temperature of the incubator) is decreased slowly according to NICU protocol until the baby is able to maintain its temperature in an open crib, without regard to the status of its feedings. This study will attempt to determine if there is a difference in length of stay, weight gain, and calories needed to gain appropriate weight between a group of newborns whose isolette temperatures are decreased in an aggressive strategy (isolette temperatures are decreased based only on baby's body temperature), and a group of newborns whose isolette temperatures are decreased in a conservative strategy (isolette temperatures are decreased to a minimum temperature and then kept steady until their feeds are at caloric goal and they are taking at least half of their feeds by mouth).

Condition Intervention
Premature Neonates Other: Conservative weaning Other: Aggressive Weaning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Conservative Weaning of Thermoregulatory Support on Weight Gain and Length of Stay in Preterm Neonates

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: Hospital discharge ]

Secondary Outcome Measures:
  • Weight gain [ Time Frame: When patient is on 120 cal/kg/day dietary intake ]
  • Caloric requirement [ Time Frame: When patient is changed to oral ad lib demand feeds ]

Enrollment: 8
Actual Study Start Date: October 22, 2008
Study Completion Date: January 26, 2011
Primary Completion Date: January 26, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aggressive Weaning
Infants will be weaned from the isolette using our current NICU standard of care.
Other: Aggressive Weaning
Infants will be weaned from the isolette based solely on their temperature without regard to feed status (current standard of care in our NICU)
Experimental: Conservative Weaning
Infants will be weaned from the isolette using a modified conservative weaning schedule.
Other: Conservative weaning
Infants will not be weaned from the isolette until their feeds are at full calorie goal (120 kcal/kg/day) and at least half of feeds are taken orally.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Live born preterm infants from 26 and 0/7 weeks gestation to 34 and 6/7 weeks gestation
  • Require thermoregulatory support
  • Are able to take feeds
  • Are presumed to be able to take oral feeds in the future

Exclusion Criteria:

  • Preterm infants less than 26 and 0/7 weeks gestation
  • Preterm infants greater than 34 and 6/7 weeks gestation
  • Infants that do not require thermoregulatory support
  • Infants that will not be able to have enteral feeds
  • Infants with endocrine disease
  • Infants with congenital anomalies
  • Infants with grade 3 or 4 intraventricular hemorrhage or other severe neurologic disability
  • Infants requiring long-term sedation
  • Infants that die within 7 days of birth
  Contacts and Locations
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): NCT00769262


Locations
United States, Missouri
Columbia Regional Hospital
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Sarah B Patton, MD University of Missouri-Columbia
  More Information

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00769262     History of Changes
Other Study ID Numbers: 1105137
First Submitted: October 8, 2008
First Posted: October 9, 2008
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Missouri-Columbia:
Premature neonates
Thermoregulation
Isolette
Feeding status

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications