Neonatal Adaptation
Conditions
Brief summary
INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in the basic technology for neonatal adaptation may not be available. Polyethylene bags may be an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the differences between babies undergoing body bag with polyethylene or conventional drying during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá, Colombia, 2013. MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag body and / or radiant heat lamp was removed. Environment temperature and humidity, temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of the outcome. The study was approved by the hospital ethics committee of victory.
Interventions
DEVICEpolyethylene plastic bag
Inborn neonates with both a gestational age \>29 weeks were randomized 1:1 to either a standard thermoregulation protocol or placement of a Poliethylene body bag since birth to 10 minutes after birth.
DEVICEConventional treatment
Infants randomized to the control group received standard hospital care newborn. This included immediate drying, skin-to-skin contact, early and exclusive breast feeding, postponed bathing, bundling, and radiant warmer. While waiting for criteria cord clamping, the environment humidity and temperature and segment and rectal temperature of the newborn were measure. It was repeated at 1-5- 10-60 and 120 minutes. After clamping, the newborn were positioned in a radiant warmer, and completed the drying process. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process was done in surgery room in case of cesarean.
Sponsors
Universidad Nacional de Colombia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Weeks to 42 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Inborn neonates with both a gestational age \>29 weeks
Exclusion criteria
* Abdominal wall defect, myelomeningocele, major congenital anomaly, or blistering skin disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature | 10 minutes | The Student's t test and U of Mann Whitney were used to compare temperature |
| Humidity | 10 minutes | The Student's t test and U of Mann Whitney were used to compare relative humidity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Both, Hypothermia or Hyperthermia | 10 minutes | Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of hypothermia, hyperthermia and APGAR. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline Charasteristics | 10 minutes | The baseline characteristics of each group were compared using descriptive statistics. The Student's t test and x2 were used to compare continuous and categorical variables, respectively. Fisher's exact test was used for events with low prevalence. |
Countries
Colombia
Outcome results
None listed