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Register:	ISRCTN
Last refreshed on:	17 October 2016
Main ID:	ISRCTN13184012
Date of registration:	19/02/2016
Prospective Registration:	Yes
Primary sponsor:	Vygon (Portugal)
Public title:	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
Scientific title:	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
Date of first enrolment:	01/03/2016
Target sample size:	80
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN13184012
Study type:	Interventional
Study design:	Interventional clinical multicenter randomized prospective controlled open-label study (Prevention)
Phase:

Countries of recruitment
Portugal

Contacts

Name:	Eduardo Fernandes
Address:	Maternidade Dr. Alfredo Da Costa Rua Viriato 1069-089 Lisbon Lisbon Portugal
Telephone:
Email:
Affiliation:

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Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Vygon (Portugal)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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