Thermoregulation in the Preterm Infant

NCT01236599 | Completed DMC

• 1 other identifier: LMCT-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the response of temperature adaptation in preterm infant using the polyethylene wrap with and without previous drying.

Conditions

Nursing Care

Keywords

preterm infant, thermoregulation, polyethylene bag

Outcome Measures

Primary Outcomes (1)

• Corporal temperature of preterm infants and Temperature of the incubator.

  Corporal temperature. An axillary thermometer of mercury was used, which was placed in the boy's armpit, making sure that it was in contact with the skin, during five minutes. Temperature of the incubator. It was directly registered from the incubator thermometer (medix TR 306). All the incubators started with a temperature of 34oC, and they were adjusted according to the necessity of preterm infant, when valuing the axillary temperature.

  every 15 minutes until the two hours of extrauterine life

Secondary Outcomes (8)

• Gestational age

  . It was valued at birth by Capurro's score

• Weight

  It was valued at birth

• Apgar score

  the minute and the five minutes of life

• Heart rate

  It was valued at birth and every 15 minutes until the two hours of extrauterine life

• Breathing frequency

  . It was valued at birth and every 15 minutes until the two hours of extrauterine life.

Study Arms (3)

traditional care

NO INTERVENTION

Preterm Infants were placed under a radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel), dried off and wrapped up in a sterile preheated field

Other: Polyethylene for thermoregulation in the preterm infant

Polyethylene bag with previous drying

EXPERIMENTAL

infants were placed under the radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel), dried off, and wrapped up in a polyethylene bag, leaving their faces discovered as well as the access at umbilical catheters or veined access.

Other: Polyethylene for thermoregulation in the preterm infant

Polyethylene bag without previous drying

EXPERIMENTAL

Preterm infants were placed under a radiant warmer (BLOSSON, Series 900, it Marks Fisher and Paykel) and without previous body drying (only the head was dried), were wrapped up with the polyethylene bag, leaving their faces discovered as well as the access to umbilical catheters or veined access

Other: Polyethylene for thermoregulation in the preterm infant

Interventions

Polyethylene for thermoregulation in the preterm infant OTHER

3 groups with 30 preterm infants (PI) each one: 1) PI under radiant warmer, drying, wrapped in sterile field preheated (traditional care), 2) PI under radiant warmer, wrapped in polyethylene bag after drying, with their naked face and access to umbilical catheters or venous access, and 3) PI under radiant warmer, without drying, wrapped in polyethylene bag, with their naked face and access to umbilical catheters or venous access. Body temperature (BT) and incubator temperature (IT) were measured every 15 minutes from birth until 120 minutes of extra uterine life.

Also known as: Heart loss in the preterm infant

Polyethylene bag with previous drying; Polyethylene bag without previous drying; traditional care

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm Infant were included according with the Official Mexican Norm -007-SSA2-1993 (1995)

You may not qualify if:

• Preterm Infant were not included in case of malformations that involved lost of the cutaneous integrity or in case of severe cardiac congenital disease.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Hospital General de Zona N 4. Instituto Mexicano del Seguro Social

Celaya, Guanajuato, 38060, Mexico

Location

Related Publications (3)

• Duman N, Utkutan S, Kumral A, Koroglu TF, Ozkan H. Polyethylene skin wrapping accelerates recovery from hypothermia in very low-birthweight infants. Pediatr Int. 2006 Feb;48(1):29-32. doi: 10.1111/j.1442-200X.2006.02155.x.

  PMID: 16490066 BACKGROUND

• Lenclen R, Mazraani M, Jugie M, Couderc S, Hoenn E, Carbajal R, Blanc P, Paupe A. [Use of a polyethylene bag: a way to improve the thermal environment of the premature newborn at the delivery room]. Arch Pediatr. 2002 Mar;9(3):238-44. doi: 10.1016/s0929-693x(01)00759-x. French.

  PMID: 11938534 BACKGROUND

• Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.

  PMID: 15580195 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Polyethylene; Body Temperature Regulation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Polyethylenes; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Body Temperature; Physiological Phenomena; Homeostasis; Adaptation, Physiological; Adaptation, Biological; Biological Phenomena

Study Officials

• Norma Amador, PhD

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 9, 2010

Record last verified: 2010-11

Locations

ME (1)