Premature InfantPAPSNCT03939169
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
A study testing Installation of a naso-gastric feeding tube in people with Premature Infant, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Infant
- What is being tested?
- Installation of a naso-gastric feeding tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2019to 13 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficiency of Using Supportive Postures and Holding Techniques in Order to Minimize Premature Infant Pain During Naso-gastric Tube Insertion, in the Presence or Absence of the Mother.
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.
Read the detailed description
Our clinical study (carried out in the Neonatology Unit of Mercy Regional Hospital) has shown that when positioning and other non drug related analgesic techniques are used, newborns undergoing naso-gastric tube insertion feel less pain.
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
- Premature Infant
- Being tested
- Installation of a naso-gastric feeding tube
- Keywords
- pain, naso-gastric tube
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Installation of a naso-gastric feeding tubeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Skin-to-skin support | Other | 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. Receives: Other: Installation of a naso-gastric feeding tube |
| Holding | Other | The newborn is held in his mother's arms during insertion of the naso-gastric feeding tube. Receives: Other: Installation of a naso-gastric feeding tube |
| Four hands care | Other | 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. Receives: Other: Installation of a naso-gastric feeding tube |
| Containing support with equipment | Other | 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. Receives: Other: Installation of a naso-gastric feeding tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (5)
Evaluation of pain using the DAN scale
This scale scores pain from 0 to 10, where 0 is no pain and 10 is maximum pain; it evaluates three items: facial expressions, limb movements and vocal expression.
Measured: Day 1
Maternal satisfaction
Mother's satisfaction with regards to her involvement in the procedure. The questions are about her sense of usefulness during the probe, her knowledge of child's reaction and her desire to repeat the experience.
Measured: Day 1
Professional's satisfaction
Health carers satisfaction during the procedure. The questions are about his appreciation of the effective management of the pain, the ease of installation, the benefits of the mother's presence and his desire to repeat the experience.
Measured: Day 1
Duration of the Naso -gastric tube in situ
Lifetime of the probe after insertion
Measured: Day 7
Procedure time
Time taken to insert the naso-gatric tube
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start15 Nov 2019
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Why it stopped: Change in Principal Investigator Role
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939169
- Sponsor's protocol ID
- 2016-07-CHRMT
- Acronym
- PAPS
- Status last verified
- Jan 2026
- First submitted
- 30 Apr 2019
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Using Supportive Postures and Holding Techniques in Order to Minimize Premature Infant Pain During Naso-gastric Tube Insertion, in the Presence or Absence of the Mother.
- ClinicalTrials.gov ID
- NCT03939169
- Acronym / sponsor ID
- PAPS / 2016-07-CHRMT
- Conditions
- Premature Infant
- Keywords
- pain, naso-gastric tube
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in Principal Investigator Role
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our clinical study (carried out in the Neonatology Unit of Mercy Regional Hospital) has shown that when positioning and other non drug related analgesic techniques are used, newborns undergoing naso-gastric tube insertion feel less pain.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Skin-to-skin support | Other | Other: Installation of a naso-gastric feeding tubeThe 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 | Other | Other: Installation of a naso-gastric feeding tubeThe newborn is held in his mother's arms during insertion of the naso-gastric feeding tube. |
| Four hands care | Other | Other: Installation of a naso-gastric feeding tubeCarried 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 | Other | Other: Installation of a naso-gastric feeding tubeCarried 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- For the newborn
- Under respiratory assistance
- With nasal or buccal malformation
- With abnormal heart rhythm or congenital heart disease
- With hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Installation of a naso-gastric feeding tubeInsertion 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 | Other | Containing support with equipment, Four hands care, Holding, Skin-to-skin support |
Primary outcome
Pain during insertion of the probe
Time frame: Day 1
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.
5 secondary outcomes
Evaluation of pain using the DAN scale
Time frame: Day 1
Maternal satisfaction
Time frame: Day 1
Professional's satisfaction
Time frame: Day 1
Duration of the Naso -gastric tube in situ
Time frame: Day 7
Procedure time
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Change in Principal Investigator Role). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Installation of a naso-gastric feeding tube in people with Premature Infant, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in Principal Investigator Role). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during insertion of the probe (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.