Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2017-05-31
2020-05-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The benefits of skin to skin described in developmental care of the newborn in the neonatal health services are well established. Nevertheless, for supposed risks (infectious and displacement of the catheter), registered in the memory of the teams, this care is not currently carried out when the newborns are carrying an umbilical venous catheter.
Sometimes, because of the presence of an umbilical venous catheter, parents and their newborns could not enjoy this moment of well-being in the first days of life. We therefore propose a study evaluating the current risks of skin to skin with an umbilical venous catheter by reflecting on a new protocol for laying and fixing this medical device.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates
NCT03585192
Skin-to-skin Contact During the Transfer From the Delivery Room to the Neonatal Intensive Care Unit: Impact on Very Preterm Infants and Their Parents
NCT05820386
Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU
NCT04761484
Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
NCT03827252
Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord
NCT03242044
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Skin to skin
Implement of skin to skin
Skin to skin
3 sessions of skin to skin will be made on newborn wearing an umbilical venous catheter
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Skin to skin
3 sessions of skin to skin will be made on newborn wearing an umbilical venous catheter
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Admitted in neonatal reanimation department at Nice's hospital
* Born in the maternity ward of the Nice's hospital
* Carriers of an umbilical venous catheter.
Exclusion Criteria
* Controlled hypothermia protocol
* Newborn under HFO (High Frequency Oscillation)
* Carrying a diaphragmatic hernia
* Thoracic drain holder
* With major PAH (hypertensive pulmonary artery)
* Symptomatic mother of acute infectious disease
* Mother whose physical or psychiatric capacity is not compatible with travel to the neonatal reanimation service within 3 days of delivery.
* Minor mother
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Florence CASAGRANDE, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Nice
Nice, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-AOI-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.