Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?

Neonatal Temperature; Kangaroo Mother Care Clinical Trial

Official title:

Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645526
• Other study ID #: CUAMMcap
• Status: Completed
• Phase: Phase 4
• First received: December 30, 2015
• Last updated: January 17, 2017
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care (KMC).

Description:

Background: Neonatal hypothermia is an important challenge associated with morbidity and mortality. Preventing neonatal hypothermia is important in high resource countries, but is of fundamental importance in low resource settings where supportive care is limited.

Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. During KMC, the World Health Organization (WHO) guidelines recommend the use of a cap/hat, but its effect temperature control during KMC remains to be established.

In the hospitals participating to the projects of the non-governmental organization CUAMM, KMC represents a standard of care, but the head of the babies often remains uncovered due to local habits or to the unavailability of a cap.

Objective: The aim of the present study will be to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during KMC.

Methods: This is a multicenter (three hospitals), multi country (three countries), prospective, unblinded, randomized clinical trial of KMC treatment with and without a woolen cap in LBWI. After obtaining parental consent, all infants with a birth weight <2500 g and candidate to KMC will be assigned to KMC with woolen cap or to KMC without cap group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome measure will be the temperature in the normal range (36.5-37.5°C) in course of KMC during the first week of life. In all participants, axillary temperature will be measured with a digital thermometer 4 times per day. In addition, maternal and room temperature will be recorded. Secondary outcome measures will be: episodes of apnea; sepsis; mortality before hospital discharge; in-hospital growth; age at discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• Birth weight <2500 g (and)

• Candidate to KMC treatment (and)

• Parental consent; a written informed consent will be obtained by a member of the neonatal - Team involved in the study from a parent or guardian before KMC treatment

Exclusion Criteria:

• Major congenital malformations

• Twins

• Parental refusal to participate to the study

Related Conditions & MeSH terms

• Neonatal Temperature; Kangaroo Mother Care

Intervention

Other:
• Woolen cap

Locations

Country	Name	City	State
Italy	Daniele TREVISANUTO	Padua	IT-Italy

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Padova	Doctors with Africa - Collegio Universitario Aspiranti Medici Missionari (CUAMM)

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Boundy EO, Dastjerdi R, Spiegelman D, Fawzi WW, Missmer SA, Lieberman E, Kajeepeta S, Wall S, Chan GJ. Kangaroo Mother Care and Neonatal Outcomes: A Meta-analysis. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-2238. Review. — View Citation

Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group.. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Review. Erratum in: Lancet. 2014 Jul 12;384(9938):132. — View Citation

Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012 May;32(5):317-24. doi: 10.1038/jp.2012.11. Review. — View Citation

Wyllie J, Bruinenberg J, Roehr CC, Rüdiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal temperature in the normal range (36.5-37.5°C) in course of KMC treatment.		First week of life.
Secondary	Number of Participants With Sepsis defined as Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.		Through study completion, an average of 2 weeks.
Secondary	Number of participants died during hospital stay.		From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 weeks.
Secondary	Rate of growth (g/kg/die) during hospital stay.		From date of randomization until the date discharge,whichever came first, assessed up to 2 weeks.
Secondary	Age at discharge.		From date of birth until the date discharge, whichever came first, assessed up to 2 weeks.