Clinical trial NCT05505903: Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission
Official title: Influence of Duration Since Birth Until Admission to Well-baby Nursery on Neonatal Temperature at Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia, Newborn
Keywords: hypothermia
friendly Cesarean section
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-08-18
Enrollment: 2412
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born at Hillel Yaffe meducal center

Brief summary: The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.

The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.

Detailed description: Introduction Friendly Cesarean section mimics normal vaginal delivery as the newborn is put on mother's chest immediately after delivery and cutting the umbilical cord, and the mother even breastfeeds the newborn infant, if she wishes to. Friendly Cesarean section is offered to the mother if there are no contraindications, such as general anesthesia, fetal distress, or prematurity. Skin to skin contacts lasts for several minutes, as long as the mothers wish to, and depend on mothers' medical state, and newborns' medical state.

In friendly Cesarean section, the skin to skin contact technique includes putting the newborn on mother's chest, and covering them both by a blanket. Yet, during Cesarean section the mother is covered by a thin paper-like sterile sheet, and as the temperature in operating room is low, her skin cools gradually from the spinal anesthesia until actually delivering the newborn infant. So, although the newborn infant is put on the mother's chest and covered by a blanket, there is a possibility for it to develop hypothermia.

Literature about this issue is rare, so the investigators conducted a study to check this possibility.

Methods In Hillel Yaffe medical center nurses measure infants temperature on admission to well-baby nursery (WBN) or neonatal intensive care unit (NICU). Admission is not always performed on arrival, due to other nurse-tasks, such as other newborn infants treatment, or breastfeeding education.

The most measureable piece of data that characterize friendly Cesarean section is the longer time interval from the birth until arrival to WBN or NICU.

Inclusion criteria: infants born within the time study interval. Exclusion criteria: infants born at less than complete 35 gestational weeks, since there is no for offer friendly Cesarean section for these births.

The investigators will collect the time interval from birth to arrival to WBN or NICU, the time interval from arrival to nurse admission, the first measured temperature, and the week of birth.

The investigators will divide the newborn infants to three groups: infants born vaginally, infants born by regular Cesarean section, and infants born by friendly Cesarean section, and compare the groups.

Eligibility criteria: Inclusion Criteria:

* all newborn infants

Exclusion Criteria:

* infants born after less than 35 complete gestational weeks

Primary outcomes:
measure: Temperature
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Neonatal intensive care unit, Hillel Yaffe medical center
Study officials:
affiliation: Hille Yaffe medical center
name: Erez Nadir, MD
role: STUDY_CHAIR
References: