Pain ScoreDOLATSONGNCT03142230
Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology
A study testing the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal and the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier in people with Pain Score, run by Centre Hospitalier Sud Francilien at 3 sites in France.
Trial summary
Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn Read more about this study
- Who is it for?
- Ages 2 to 14 days
- Conditions the study is for
- Pain Score
- What is being tested?
- the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal and the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Oct 2016to 13 Aug 2018
- 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 2 to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn term, or premature (from 32 weeks) from 48 hours to 14 days of life.
- Presence of sucking reflex
- Patient whose authors of parental authority have given their written consent for their participation
- Patient affiliated to or benefiting from a social security scheme
Who cannot join
- Newborn intubated or NIV and / or sedated
- Newborn with malformation (especially cleft palate)
- Contra-indication to sugar administration
- Newborn previously included in the study
- Administration of analgesics in the previous 8 hours
- Atresia of the unoperated esophagus
Show all 9Show fewer
- Non-operated oeso-tracheal fistula
- Major swallowing disorders
- Necrotizing ulcerative colitis
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
Groupe Hospitalier Paris Saint-Joseph
Paris, 75014
Centre Hospitalier de Saint-Denis
Saint-Denis, 93200
About this study
Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn
Read the detailed description
After inclusion, the nurse performs randomization by opening the envelope. The newborn then receives the care with the introduction of the gastric tube after randomization (experimental arm with holed baby bottle nipple and control arm: with pacifier). The treatment is filmed and recorded by a previously installed camera. The films are viewed by two independent experts from the pain of the study, to assess pain by scale score (DAN acute pain of the newborn
- Conditions
- Pain Score
- Being tested
- the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal, the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier
- Keywords
- feeding tube, gastric, newborn infant, nursing, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngealOther
The newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple
the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifierOther
The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier
| Study group | Role | What they receive |
|---|---|---|
| non-nutritive suction with holed baby bottle nipple | Experimental | A group using the holed baby bottle nipple Receives: Other: the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal |
| Simple non-nutritive suction with personal pacifier | Active comparator | A group using personal pacifier Receives: Other: the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain evaluation
DAN SCALE
Measured: Time of nurse care - thirty minutes maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start14 Oct 2016
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ScoreStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, controlled, randomized, multicentric, open-label, randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de Ressources de lutte contre la Douleur
- Responsible party
- Sponsor
- Investigators
- Michele Granier, MD, Study director, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142230
- Sponsor's protocol ID
- 2015-A00427-42
- Acronym
- DOLATSONG
- Status last verified
- Oct 2019
- First submitted
- 28 Mar 2017
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Darretain H, Laborne FX, Lagadec S, Garrigue B, Maillard F, Harbi F, Waszak P, Granier M, Galand N, Walter-Nicolet E, Razafimahefa H. An Analgesic Technique for Orogastric Tube Insertion in Newborns: DOLATSONG, a Randomized Multicentric Controlled Trial. J Perinat Neonatal Nurs. 2024 Oct-Dec 01;38(4):361-368. doi: 10.1097/JPN.0000000000000746. Epub 2024 Nov 7.
PubMed 38833575
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology
- ClinicalTrials.gov ID
- NCT03142230
- Acronym / sponsor ID
- DOLATSONG / 2015-A00427-42
- Conditions
- Pain Score
- Keywords
- feeding tube, gastric, newborn infant, nursing, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Collaborators
- Centre National de Ressources de lutte contre la Douleur
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 5 May 2017 (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.
Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn
Detailed description
After inclusion, the nurse performs randomization by opening the envelope. The newborn then receives the care with the introduction of the gastric tube after randomization (experimental arm with holed baby bottle nipple and control arm: with pacifier). The treatment is filmed and recorded by a previously installed camera. The films are viewed by two independent experts from the pain of the study, to assess pain by scale score (DAN acute pain of the newborn
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, controlled, randomized, multicentric, open-label, randomized study
| Arm | Type | Receives |
|---|---|---|
| non-nutritive suction with holed baby bottle nipple | Experimental | Other: the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngealA group using the holed baby bottle nipple |
| Simple non-nutritive suction with personal pacifier | Active comparator | Other: the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifierA group using personal pacifier |
Who may qualify
- Ages
- 2 to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborn term, or premature (from 32 weeks) from 48 hours to 14 days of life.
- Presence of sucking reflex
- Patient whose authors of parental authority have given their written consent for their participation
- Patient affiliated to or benefiting from a social security scheme
Key exclusion criteria (9 listed)
- Newborn intubated or NIV and / or sedated
- Newborn with malformation (especially cleft palate)
- Contra-indication to sugar administration
- Newborn previously included in the study
- Administration of analgesics in the previous 8 hours
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 |
|---|---|---|
| the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngealThe newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple | Other | non-nutritive suction with holed baby bottle nipple |
| the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifierThe newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier | Other | Simple non-nutritive suction with personal pacifier |
Primary outcome
pain evaluation
Time frame: Time of nurse care - thirty minutes maximum
DAN SCALE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Derived from this study: PubMed 38833575Darretain H, Laborne FX, Lagadec S, Garrigue B, Maillard F, Harbi F, Waszak P, Granier M, Galand N, Walter-Nicolet E, Razafimahefa H. An Analgesic Technique for Orogastric Tube Insertion in Newborns: DOLATSONG, a Randomized Multicentric Controlled Trial. J Perinat Neonatal Nurs. 2024 Oct-Dec 01;38(4):361-368. doi: 10.1097/JPN.0000000000000746. Epub 2024 Nov 7.
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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.
Michele Granier, MD study director
Centre Hospitalier Sud Francilien
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal and the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier in people with Pain Score, run by Centre Hospitalier Sud Francilien at 3 sites 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 9 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: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 evaluation (time frame: Time of nurse care - thirty minutes maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142230, which also lists 1 linked publication.
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 21 Oct 2019.