Weaning Preterm Infants at 1500 Grams From Incubators

NCT01083303 | Completed

• 1 other identifier: TASMC08BI05089CTIL
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Infants

Keywords

energy expenditure; hypothermia; body temperature; weaning; preterm infants

Outcome Measures

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.

  Ten days

Secondary Outcomes (1)

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

  Fourty eight hours

Study Arms (2)

weaning at 1500 g

EXPERIMENTAL

weaning infants from an incubator at 1500 g

Behavioral: Weaning Preterm Infants from an incubator

weaning at 1600 g

ACTIVE COMPARATOR

weaning infants from an incubator at 1600 g

Behavioral: Weaning Preterm Infants from an incubator

Interventions

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.

weaning at 1500 g; weaning at 1600 g

Eligibility Criteria

• Age: 14 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ventilated infants or those requiring oxygen supplementation
• parenteral nutrition
• antibiotic treatment or steroids treatment were excluded

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Neonatology department Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaul Dollberg, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: March 9, 2010
• Study Start: May 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

IL (1)