The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
NCT ID: NCT03939169
Last Updated: 2023-12-21
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.
SUSPENDED
NA
120 participants
INTERVENTIONAL
2019-11-15
2027-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Several different techniques were used, such as skin-to-skin contact with the mother and/or positioning the infant using appropriate equipment, or the "four hands" technique carried out by two health care professionals.
Neonatal unit staff were able to choose the method used depending on whether the mother was present at the time of the procedure.
In cases where the mother was absent, the "four hands technique" was favored, but in the presence of the mother skin-to-skin contact was preferable.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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 support
The newborn is dressed in one layer of clothing with a hat, he is placed in the ventral position directly on the mother's chest, covered with a warm blanket and held in place with a band during the insertion of the naso-gastric feeding tube.
Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
Holding
The newborn is held in his mother's arms during insertion of the naso-gastric feeding tube.
Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
Four hands care
Carried out by two professionals: one health-care professional supports the child and helps stabilize the newborn whilst the other professional inserts the naso-gastric feeding tube.
Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
Containing support with equipment
Carried out by one healthcare Professional, who places the newborn in such a manner that he will be held in the optimum position (using a soft sheet) during the insertion of the naso-gastric feeding tube.
Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Installation of a naso-gastric feeding tube
Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Prescription of enteral nutrition via naso-gastric tube
* Naso-gastric tube in-situ
* Informed consent of both parents
Exclusion Criteria
* Under respiratory assistance
* With nasal or buccal malformation
* With abnormal heart rhythm or congenital heart disease
* With hemodynamic instability
* Transfer to type 3 neonatal unit
* With a DAN score \> 0 before treatment
* With an umbilical venous catheter in-situ
* Fed with thickened milk
* Prescription of analgesic medications
For the parents
* Minor
* Under legal protection
* Difficulties which do not permit the mother to carry out skin-to skin contact or holding support
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Régional Metz-Thionville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHR Metz Thionville
Metz, , 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.
2016-07-CHRMT
Identifier Type: -
Identifier Source: org_study_id