Weaning Preterm Infants at 1500 Grams From Incubators

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01083303
First received: July 2, 2009
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Background: The weight at which infants are weaned from incubators varies among neonatal units.

Objective: To determine the effect on weight gain, temperature stability and resting energy expenditure (REE) of weaning infants at body weight of 1500 g versus 1600 g.

Design/Methods: infants will be randomized to incubator weaning at the weight of 1500 g or 1600 g. Preterm infants 1500 g birth weight, fully enterally fed, and without supplemental oxygen, at the postnatal age of 2 weeks will be included. Infants will be weaned to a warming bassinet (Babytherm 8000, Dräger) set to keep a mattress temperature of 37°C while decreasing it gradually to room temperature. Failure to wean is defined as core body temperature of < 36.1°C. Data collection included skin and rectal temperature obtained before weaning, and at 1/2, 1, 2, 6, 24, and 48 hours after weaning, weekly weight gain (g/kg/d). REE (kcal/kg/24h) will be measured by indirect calorimetry (Deltatrac II, Finland) before and 24 hours after weaning.


Condition Intervention
Preterm Infants
Behavioral: Weaning Preterm Infants from an incubator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Weaning Preterm Infants at 1500g From Incubators: Effect on Failure to Wean, Weight Gain and Energy Expenditure

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • successful and safe weaning from convective incubator of stable preterm infants to a warming bassinet at body weight of 1500g compared with 1600g. [ Time Frame: Ten days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Resting energy expenditure REE (kcal/kg/24h) measurements [ Time Frame: Fourty eight hours ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: May 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: weaning at 1500 g
weaning infants from an incubator at 1500 g
Behavioral: Weaning Preterm Infants from an incubator
Eligible infants are to be randomized by computer generated random numbers to either the study group weaned at 1500 gr. or the control group weaned at 1600 gr. Both groups were weaned to a warming bassinet.
Active Comparator: weaning at 1600 g
weaning infants from an incubator at 1600 g
Behavioral: Weaning Preterm Infants from an incubator
Eligible infants are to be randomized by computer generated random numbers to either the study group weaned at 1500 gr. or the control group weaned at 1600 gr. Both groups were weaned to a warming bassinet.

Detailed Description:

Eligible infants will be randomized by computer generated random numbers, to either the study group weaned at 1500 g or the control group weaned at 1600 g. Both groups will be weaned to a warming bassinet (Babytherm 8000, Drager). The Babytherm 8000 WB is an open care infant warming system with a warmed gel mattress with temperature control . The system is set to keep the mattress temperature of 37 degrees Celsius while decreasing it gradually to 32 0C and shutting the system off. On transfer to the Babytherm infants are dressed with a hat and two vests. Only after the infant maintained a normal body temperature under these conditions he could be transferred to an open bassinet. Failure to wean was defined as core body temperature of <36.10C.

Data collection included skin and rectal temperature obtained before weaning, and at 1/2, 1, 2, 6, 24, and 48 hours after weaning, daily and weekly weight gain (g/kg/d). Resting Energy Expenditure- REE (kcal/kg/24h) is measured by indirect calorimetry (Deltatrac II, Finland) before and 24 hours after weaning to the warming bassinet.

Data Collection included: PR temperature after 30 min, 60 min, 2 hours, 6 hours, 24 hours, after which temperatures were taken 4-hourly until 48 hours (degrees C), skin (axillary) temperature (degrees C), after 30 min, 60 min, 2 hours, 6 hours, and than again every 4 hours until 48 hours. REE (kcal/kg/24h)rate of hypothermia requiring return to the incubator, weight gain after 24 hours of weaning and over 1 week.( g/kg/d),time to discharge ( days).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable preterm infants weighing ≤1500 g
  • fully enterally fed, and without supplemental oxygen
  • steroid or antibiotics treatment
  • at the postnatal age of ≥ 2 weeks were included
  • infants < than 2 weeks of age

Exclusion Criteria:

  • ventilated infants or those requiring oxygen supplementation
  • parenteral nutrition
  • antibiotic treatment or steroids treatment were excluded
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01083303

Locations
Israel
Neonatology department Tel Aviv Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Shaul Dollberg, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01083303     History of Changes
Other Study ID Numbers: TASMC08BI05089CTIL
Study First Received: July 2, 2009
Last Updated: August 1, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
energy expenditure
hypothermia
body temperature
weaning
preterm infants

ClinicalTrials.gov processed this record on August 28, 2014