Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth

NCT04865302 | Completed

• 1 other identifier: Kangaroo
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in ventilated preterm neonates on the first day after birth.

Conditions

Preterm Birth; Ventilator Lung; Newborn

Outcome Measures

Primary Outcomes (3)

• percent minutes of cerebral hypoxia

  After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "incubator phase I" over 40 minutes.

  60 minutes

• percent minutes of cerebral hypoxia

  After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "SSC" over 40 minutes.

  60 minutes

• percent minutes of cerebral hypoxia

  After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "incubator phase II" over 40 minutes.

  60 minutes

Secondary Outcomes (21)

• Mean StO2

  60 minutes

• Mean StO2

  60 minutes

• Mean StO2

  60 minutes

• Mean cFTOE

  60 minutes

• Mean cFTOE

  60 minutes

Other Outcomes (3)

• leukocyte count

  first 48 hours

• C-reactive protein

  first 48 hours

• IT-ratio

  first 48 hours

Interventions

SSC PROCEDURE

Incubator phase I: After feeding the neonates will be brought in a prone position in the incubator and the NIRS sensor will be applied on the forehead for continuous cStO2 measurements throughout the study period. The neonate will rest in this position for 60 minutes. SSC phase: The neonate will be brought on the mother's or father's chest (skin to skin) in a prone position and will stay in this position for 60 minutes. Incubator phase II: The neonates will be brought back into the incubator for another 60 minutes in prone position. After 180 minutes the study period is over and the NIRS sensor will be removed.

Eligibility Criteria

• Age: 15 Minutes - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates \<37+0 weeks of gestation admitted to the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz after vaginal delivery or caesarean section will be eligible for the study.

You may qualify if:

• Need for respiratory support (endotracheal tube \[ETT\], nasal continuous positive airway pressure \[nCPAP\], high-flow nasal cannula \[HFNC\])
• Decision to conduct full life support
• Written informed consent

You may not qualify if:

• No decision to conduct full life support
• No written informed consent
• Severe congenital malformations, severe asphyxia (umbilical cord artery pH \<7.00)
• Cerebral malformations, posthaemorrhagic ventricular dilatation, intraventricular haemorrhage grade III, periventricular haemorrhage
• Cardiovascular instability (need for catecholamines)
• No need for respiratory support

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Pediatrics, Division of Neonatology, Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nina Höller, MD

  Medical University of Graz, Department of Paediatrics and Adolescent Medicine, Devision of Neonatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: October 1, 2021
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: December 2, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)