Prevention of hypothermia, in the immediate neonatal period, in infants with gestational age ≤28 weeks: a comparative study of the effectiveness of two models of polyethylene bags

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Informed consent will be obtained from one of the parents before birth. ?Randomization (1: 1) of newborns, for one of the two groups, will be performed immediately before delivery, through closed opaque envelope opening, numbered sequentially, which contains the assigned study group (intervention or control), obtained by table of random numbers generated by computer (variable block randomization for 2 to 4). Concealment of the intervention is not possible. Newborn twins will be randomized individually. After childbirth and verifying the absence of exclusion criteria, the only difference in care between the two groups is the intervention: newborns randomized to the intervention group are placed immediately, without drying, in Neohelp TM bag and the newborns randomized to the control group are placed immediately, without drying, in the usual bags, with drying and head cover with a cap. The remaining practices, stabilization/resuscitation, transport to the Neonatal Intensive Care Unit (NICU) and routine care are determined by the usual practice of the units and will be the same in the two groups. After admission to the NICU, removing the polyethylene bag is held after the placement of central pathways and stabilization of body temperature (36.5‐37,5ºC) in the incubator with 85% humidity. The following variables will be recorded and monitored: 1. Delivery room ambient temperature (°C), immediately before the birth, with environmental pattern thermometer 2. Maternal temperature at delivery (°C) 3. Date and time of birth (hh:mm) 4. Time (hh:mm) and skin temperature (°C) of newborn in admission on the NICU, using skin temperature sensor, placed in the liver area 5. Newborn’s temperature (° C) 1 hour after admission 6. Gestational age (weeks and days) 7. Birth weight (grams) 8. Sex 9. Twinning and birth order 10. Type of delivery (cesarean section or vaginal) 11. Maternal fever (> 37.5 ° C) 12. Chorioamnionitis 13. Tracheal intubation at birth 14. Need of advanced res CONDITION: Prevention of hypothermia, in the immediate neonatal period, in infants with gestational age =28 weeks ; Neonatal Diseases ; Hypothermia of newborn PRIMARY OUTCOME: The effectiveness of the two polyethylene bag models in the prevention of neonatal hypothermia immediately after birth by measuring skin temperature of newborns on admission to the NICU SECONDARY OUTCOME: Comparison of the two groups for the following secondary variables related with hypothermia:; 1. Metabolic acidosis; 2. Hypotension; 3. Hypoglycemia; 4. Patent ductus arteriosus with hemodynamic significance; 5. Necrotizing enterocolitis; 6. Isolated gastrointestinal perforation; 7. Respiratory distress syndrome; 8. Pulmonary hemorrhage; 9. Pneumothorax; 10. Bronchopulmonary dysplasia; 11. Intraventricular hemorrhage; 12. Periventricular leukomalacia; 13. Retinopathy of prematurity; 14. Sepsis; 15. Hospital stay; 16. Mortality; 17. Causes of death; Secondary outcomes will be measured until date of hospital discharge. INCLUSION CRITERIA: 1. Newborn infants with gestational age between 24 weeks and 0/7 days and 28 weeks and 0/7 days, according to the best obstetric estimate 2. Born in Dr. Alfredo da Costa Maternity and Professor Dr. Fernando Fonseca Hospital 3. With informed consent
Epistemonikos ID: 529e435aafcea38ef81a94a3c0c371fa39ee730e
First added on: Aug 24, 2024