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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13184012

Enrollment

Registered

2016-02-19

Start date

2016-03-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 opaq

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026