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

Completed

• Conditions: Prevention of hypothermia, in the immediate neonatal period, in infants with gestational age =28 weeks; Neonatal Diseases; Hypothermia of newborn

• Registration Number: ISRCTN13184012
• Lead Sponsor: Vygon (Portugal)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-19
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

1. Newborns with congenital anomalies not covered by skin (gastroschisis, myelominingocele) or with skin lesions that prevent the skin covering with polyethylene bag
2. Deceased in the delivery room

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 NIC

Secondary Outcome Measures

Name	Time	Method
Comparison of the two groups for the following secondary variables related with hypothermia:<br>1. Metabolic acidosis<br>2. Hypotension<br>3. Hypoglycemia<br>4. Patent ductus arteriosus with hemodynamic significance<br>5. Necrotizing enterocolitis<br>6. Isolated gastrointestinal perforation<br>7. Respiratory distress syndrome<br>8. Pulmonary hemorrhage<br>9. Pneumothorax<br>10. Bronchopulmonary dysplasia<br>11. Intraventricular hemorrhage<br>12. Periventricular leukomalacia<br>13. Retinopathy of prematurity<br>14. Sepsis<br>15. Hospital stay<br>16. Mortality<br>17. Causes of death<br>Secondary outcomes will be measured until date of hospital discharge.