Study the effect of a plastic cap during the resuscitation of a preterm infant on heat loss and temperature at admission to the NICU.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
temperatuur controle bij prematuur
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Does the use of a plastic cap in preterm infants born by caeserean section
reduces heat loss, measured after admission to the NICU
Secondary outcome
remains this effect during the first 2 hours after admission to the NICU.
Background summary
An important item in the care of preterm infants is the maintenance of a
neutral body temperature. The smaller and more immature the infant is, the
higher the risk of heat loss. Hypothermia in the preterm infant increase the
risk of respiratory and cardiovascular instability. The risk of heat loss is
the greatest at birth, especially when the infant is born in a cold environment
as the operating room. Despite the measurements taken to prevent heat loss such
as wrapping the body in plastic substantial heat loss still occurs.
We speculate that covering the heat in plastic could prevent heat loss. In
preterm infant the head is large compared to the body and is it known that this
results in substantial heat loss, which can only be partly prevented by the
normal cap now used.
Study objective
Study the effect of a plastic cap during the resuscitation of a preterm infant
on heat loss and temperature at admission to the NICU.
Study design
Randomised controlled trial. Blinding is not possible due to the visible aspect
of the cap.
If a pregnant woman is admitted to the obstretic ward the attending
neonatologist or the investigator will ask permission for the study to the
future parents.
Before every birth of an infant < 32 weeks with a caeserean section infants
will be stratified and randomised to be treated with a plastic cap or the usual
tricot cap. Immediately afer birth the cap will be put on the head of the
infant and will remain there during the first 2 hours after admission on the
NICU. The control group with the tricot cap will get a clean and dry cap when
they are admitted to the unit. This cap will remain during the first 2 hours
after admission. Body temperature will by measured rectally immediately after
admission on the NICU and 1 and 2 hours later skin measurements will be taken.
The plastic cap will be manufactured by the investigator since these caps are
not commercially available.
Intervention
all infants will be rsuscitated according to the excisting protocol. This means
that they will be put on a Panda®Warmer and put immediately in a plastic bag
without previous drying. All infants get a cap immediately after birth. When
used a tricot standard cap (control group) the head will be dried before the
cap is put on the head. When a plastic cap is used (study group) the head is
not dried and the cap is put on immediately. After stabilisation of the infant,
the infant is transported to the NICU in a transport incubator and admitted to
the unit in an incubator and treated according to the unit policy.
Standard cap
in the Isala clinics tricot caps are used (infant caps, Medline Industies,
Inc.). After admission to the unit this cap will be replaced by a dry cap.
Plastic cap
these cap will be made by the investigator since these caps are not
commercially available. There has been contact with a previous investigator on
this topic (D.Trevisanuto), she also used hand made caps.
Study burden and risks
Not applicable
Temperature measurements are standard procedure for all preterm infants. We
expect that the texture of the cap (plastic instead of tricot) wil not
substantially disturbe the infant.
Dr van Heesweg 2
8025 AB Zwolle
NL
Dr van Heesweg 2
8025 AB Zwolle
NL
Listed location countries
Age
Inclusion criteria
preterm infants < 32 weeks
born by caesarean section in the Isala clinics Zwolle
admitted to the NICU Isala clinics Zwolle
Exclusion criteria
severe congenital malformations
severe skin defects
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL38253.075.11 |