Study Stopped
Change in Principal Investigator Role
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
PAPS
1 other identifier
interventional
4
1 country
1
Brief Summary
Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out. It has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. However, this has not yet been proven with regards to naso-gastric tube insertion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2020
CompletedJanuary 23, 2026
January 1, 2026
12 months
April 30, 2019
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain during insertion of the probe
Evaluation of the newborn's pain during insertion of the naso-gastric tube using the Premature Infant Pain Profile (PIPP) scale. The PIPP consists of 3 behavioral (facial actions: brow bulge, eye squeeze, and nasolabial furrow) and 2 physiological (heart rate and oxygen saturation) indicators, and 2 contextual \[gestational age (GA) and behavioral state\] variables that modify pain. In the same time, the heart rate and oxygen saturation of the newborns were measured using a pulse oximeter.
Day 1
Secondary Outcomes (5)
Evaluation of pain using the DAN scale
Day 1
Maternal satisfaction
Day 1
Professional's satisfaction
Day 1
Duration of the Naso -gastric tube in situ
Day 7
Procedure time
Day 1
Study Arms (4)
Skin-to-skin support
OTHERThe 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.
Holding
OTHERThe newborn is held in his mother's arms during insertion of the naso-gastric feeding tube.
Four hands care
OTHERCarried 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.
Containing support with equipment
OTHERCarried 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.
Interventions
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
You may qualify if:
- Preterm baby born between the 32th and the 35th weeks of amenorrhea plus 6 days
- Prescription of enteral nutrition via naso-gastric tube
- Naso-gastric tube in-situ
- Informed consent of both parents
You may not qualify if:
- For the newborn
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHR Metz Thionville
Metz, 57085, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2019
First Posted
May 6, 2019
Study Start
November 15, 2019
Primary Completion
November 13, 2020
Study Completion
November 13, 2020
Last Updated
January 23, 2026
Record last verified: 2026-01