Ignite Creation Date:
2024-05-06 @ 8:00 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02645526
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2015-12-30
Brief Title:
Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care
Sponsor:
University Hospital Padova
Organization:
University Hospital Padova
Study Overview
Official Title:
Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 caphat 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 11 ratio according to a computer-generated randomized sequence The primary outcome measure will be the temperature in the normal range 365-375C 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
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 caphat 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 11 ratio according to a computer-generated randomized sequence The primary outcome measure will be the temperature in the normal range 365-375C 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None