Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02803606

Acronym

PREMARISQ

Enrollment

Registered

2016-06-17

Start date

2009-06-30

Completion date

2012-06-30

Last updated

2018-08-10

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

Conditions

Hypothermia

Keywords

hypothermia, routine care, preterm neonates

Brief summary

Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit will be included after informing the parents. Abdominal skin and peripheral (arm or leg) and incubator air temperatures and relative humidity will be obtained from data recorded by the incubator without using any additional transducer compared to standard care. Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization will also be recorded from routine monitoring. A case report form and a wide-angle video recording of the infant's room will allow description of the type of care, determine the duration of care and the impact on incubator function. Data will be recorded for the first 7 days of life of the preterm neonate.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Weeks to 32 Weeks

Healthy volunteers

Inclusion criteria

* Preterm infants of 25-32 weeks of gestation * Birth in one of the two maternity hospitals of Amiens agglomeration (CGO or clinic of Europe ) * Arrived in the Neonatal Medicine unit \< 2 hours of life * Necessitated a care in an incubator

Exclusion criteria

* Preterm infants \> 32 weeks of gestation * Birth outside the Amiens metropolitan area * Arrived in the Neonatal Medicine unit after 2 hours of life * Present a malformation syndrome or severe heart disease * Pathology requiring support within the first 7 days of life * Apgar score \< 5 to 10 minutes of life * Need for initial management in open incubator * Unavailability of a type of incubator Caleo®

Design outcomes

Primary

Measure	Time frame
Lowest abdominal skin temperature	20 minutes

Secondary

Measure	Time frame
Pulse rate	20 minutes
Morbidity	7 days
The nadir for peripheral skin temperature	20 minutes
respiratory rate	20 minutes
Blood pressure	20 minutes
mortality	7 days

Countries

France

Outcome results