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Completed

NCT Number: NCT01083303

Weaning Preterm Infants at 1500 Grams From Incubators

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.

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Key information

Age range

14 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatology department Tel Aviv Medical Center

Tel Aviv, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weaning Preterm Infants from an incubator

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Resting energy expenditure REE (kcal/kg/24h) measurements

    Time frame: Fourty eight hours

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

A Randomized Trial of Weaning Preterm Infants at 1500g From Incubators: Effect on Failure to Wean, Weight Gain and Energy Expenditure

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Mar 9, 2010
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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