Premature NewbornsPREMAMANDOLNCT06200662
Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture
A study testing Analgesic strategies during the S visit: and Analgesic strategies at visit M in people with Premature Newborns, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Extremely premature newborn infants (ELNs) admitted to hospital are exposed to stressful and painful stimuli, and often to maternal separation, which can affect their long-term neurological development. Read more about this study
- Who is it for?
- Ages 32 to 34 weeks
- Conditions the study is for
- Premature Newborns
- What is being tested?
- Analgesic strategies during the S visit: and Analgesic strategies at visit M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2024to 7 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 32 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very premature babies born before the gestational age (GA) of 32 weeks of amenorrhoea (SA) whose corrected age (CA) does not exceed 34 SA at the time of their participation.
- NN requiring close biological monitoring by a PV.
- Hospitalised in the NN medicine and intensive care unit at Strasbourg hospital.
- Consent obtained from both holders of parental authority.
- Person covered by a social health insurance scheme.
Who cannot join
- Any known malformation affecting one or more organs.
- Cerebral lesions discovered o n cerebral ultrasound (intraventricular haemorrhage grade > 2, periventricular leukomalacia).
- Unstable clinical state as judged by the investigator and the medical team.
- Transfer to another hospital centre expected before the end of the study period.
- Mother: Minor. Deprived of liberty by judicial or administrative decision. Under legal protection. Severe psychological pathology. Drug addiction. Difficulty understanding and/or reading the language.
- French.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires
Strasbourg, Bas-Rhin, 67091
Elodie RABATEL, +33388127785, elodie.rabatel@chru-strasbourg.fr
Pierre KUHN
About this study
Official title: Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture: Effectiveness, Experiences of Parents and Carers
Extremely premature newborn infants (ELNs) admitted to hospital are exposed to stressful and painful stimuli, and often to maternal separation, which can affect their long-term neurological development. Child- and family-centred developmental care (CFDC) in neonatology aims to adapt the hospital environment to the needs of the child, support the continued presence of the family and help to improve their future.
Specific assessment and appropriate analgesic treatment are therefore priorities for preserving the well-being and cerebral development of this population, which is particularly vulnerable to pain. Pain relief for certain procedures necessary for the care of newborn babies, such as venipuncture (PV), remains inadequate. Venipuncture is a common procedure in the first few weeks of life for very premature newborns. Its analgesic treatment is based on non-medicinal strategies largely carried out in the nurse's own role: non-nutritive suctioning combined with the administration of a sugar solution and wrapping. In line with the SDCEF philosophy, and reinforced by the "zero separation" concept, parental involvement in the treatment of their newborn's pain becomes natural and fundamental. A number of studies have shown the benefits of parents' presence and participation through specific isolated analgesic actions. Skin- to-skin contact (PAP) is one of these and has multiple benefits for the newborn. However, in practice, when a PV is necessary for a very premature baby, its use as a pain-relieving strategy is hampered by a number of obstacles. As NN are naturally oriented towards the maternal voice, using it is a new approach to analgesia. In an innovative study carried out in a single centre, direct maternal voice contact, in addition to the usual non- pharmacological analgesic strategies, reduced the NN's pain, without completely eliminating it during heel sampling (a skin incision known to be more painful than a PV). This analgesic strategy should therefore be combined with other non-pharmacological strategies, taking advantage of all maternal skills.
Read the detailed description
- Information visit (V0 - 1 day): parents are informed by the clinical research nurse (CRN);
- Inclusion visit (V0): inclusion, collection of consent from the 2 holders of parental authority, collection of anamnestic data by the CRI;
- Visit S and visit M (V0 to ≤ 7 d): random order, installation of the NN in a room dedicated to recordings, analgesic strategies (see below), performance at each visit of a PV (necessary for care) by the IRC, collection of behavioural data by video sequences centred on the NN's face.
Analgesic strategies during the S visit: standard and recommended non-pharmacological analgesic strategies used by the CRI: administration of sugar solution, support for non-nutritive sucking with a dummy and wrapping in a nappy.
Analgesic strategies at visit M: overall non-pharmacological analgesic strategies carried out by the mother: sucking on a sugar solution, supporting non-nutritive sucking with a dummy, contact, etc.
direct voice (from 5 minutes before to 5 min after PV), wrap in a nappy and manual, and offer to grasp the finger.
Analysis of behavioural data: NFCS scores obtained from analysis of video sequences by 10 s periods (basal, per and post stimulation) by 2 blind assessors on the type of analgesia used (carer or mother).
- Conditions
- Premature Newborns
- Being tested
- Analgesic strategies during the S visit:, Analgesic strategies at visit M
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic strategies during the S visit:Other
Analgesic strategies during the S visit: standard and recommended non-pharmacological analgesic strategies used by the CRI: administration of sugar solution, support for non-nutritive sucking with a dummy and wrapping in a nappy.
Analgesic strategies at visit MOther
Analgesic strategies at visit M: overall non-pharmacological analgesic strategies carried out by the mother: sucking on a sugar solution, supporting non-nutritive sucking with a dummy, contact, etc.
| Study group | Role | What they receive |
|---|---|---|
| premature newborns | Other | premature newborns . 2 groups composed of the same children but benefiting from 2 different analgesic strategies, each applied at one of two different times. The groups compared were the "order S then M" group and the "order M then S" group. Receives: Other: Analgesic strategies during the S visit:; Other: Analgesic strategies at visit M |
| premature | Other | premature newborns . 2 groups composed of the same children but benefiting from 2 different analgesic strategies, each applied at one of two different times. The groups compared were the "order S then M" group and the "order M then S" group. Receives: Other: Analgesic strategies during the S visit:; Other: Analgesic strategies at visit M |
What is being measured
The primary outcome is the main question the study is designed to answer.
NFCS (Neonatal Facial Coding System)
the NFCS pain score assessed during a PV in two conditions:
- maternal absence: "carer" analgesia (visit S) ;
- maternal involvement: "mum" pain (M visit). This is a validated 4-item scale describing facial mimics in NN. The analysis was based on video sequences and blinded to the type of analgesia used. The possible score is from 0 to 4 and will be binarised to a value of "1"; the primary endpoint (PEC) is therefore the proportion of neonates with a score of "1". greater than or equal to 1.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start22 Feb 2024
- Primary completion7 Jan 2028 (estimated)
- Study completion7 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NewbornsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- This is a single-centre crossover study which plans t o include up to 48 newborns (objective: 40 analysable subjects, visit S and visit M carried out) for whom two different analgesic strategies will be applied, each at one of the two time points of the crossover: * a control treatment, referred to here as treatment S: standard and recommended non- pharmacological analgesic strategies carried out by the carer alone * an experimental treatment, referred to here as treatment M: overall non-pharmacological analgesic strategies carried out by the mother The groups are therefore the "order S then M" group and the "order M then S" group. The order of visits was determined randomly (prior randomisation) for each mother-child dyad.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elodie RABATEL, Principal investigator, Médecine et Réanimation du Nouveau-né Hôpital de Hautepierre CHU de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200662
- Sponsor's protocol ID
- 8836
- Acronym
- PREMAMANDOL
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2023
- Last updated
- 9 Jun 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture: Effectiveness, Experiences of Parents and Carers
- ClinicalTrials.gov ID
- NCT06200662
- Acronym / sponsor ID
- PREMAMANDOL / 8836
- Conditions
- Premature Newborns
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 7 Jan 2028 (estimated)
- Study completion
- 7 Feb 2028 (estimated)
- First posted
- 11 Jan 2024 (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.
Extremely premature newborn infants (ELNs) admitted to hospital are exposed to stressful and painful stimuli, and often to maternal separation, which can affect their long-term neurological development. Child- and family-centred developmental care (CFDC) in neonatology aims to adapt the hospital environment to the needs of the child, support the continued presence of the family and help to improve their future.
Specific assessment and appropriate analgesic treatment are therefore priorities for preserving the well-being and cerebral development of this population, which is particularly vulnerable to pain. Pain relief for certain procedures necessary for the care of newborn babies, such as venipuncture (PV), remains inadequate. Venipuncture is a common procedure in the first few weeks of life for very premature newborns. Its analgesic treatment is based on non-medicinal strategies largely carried out in the nurse's own role: non-nutritive suctioning combined with the administration of a sugar solution and wrapping. In line with the SDCEF philosophy, and reinforced by the "zero separation" concept, parental involvement in the treatment of their newborn's pain becomes natural and fundamental. A number of studies have shown the benefits of parents' presence and participation through specific isolated analgesic actions. Skin- to-skin contact (PAP) is one of these and has multiple benefits for the newborn. However, in practice, when a PV is necessary for a very premature baby, its use as a pain-relieving strategy is hampered by a number of obstacles. As NN are naturally oriented towards the maternal voice, using it is a new approach to analgesia. In an innovative study carried out in a single centre, direct maternal voice contact, in addition to the usual non- pharmacological analgesic strategies, reduced the NN's pain, without completely eliminating it during heel sampling (a skin incision known to be more painful than a PV). This analgesic strategy should therefore be combined with other non-pharmacological strategies, taking advantage of all maternal skills.
Detailed description
- Information visit (V0 - 1 day): parents are informed by the clinical research nurse (CRN);
- Inclusion visit (V0): inclusion, collection of consent from the 2 holders of parental authority, collection of anamnestic data by the CRI;
- Visit S and visit M (V0 to ≤ 7 d): random order, installation of the NN in a room dedicated to recordings, analgesic strategies (see below), performance at each visit of a PV (necessary for care) by the IRC, collection of behavioural data by video sequences centred on the NN's face.
Analgesic strategies during the S visit: standard and recommended non-pharmacological analgesic strategies used by the CRI: administration of sugar solution, support for non-nutritive sucking with a dummy and wrapping in a nappy.
Analgesic strategies at visit M: overall non-pharmacological analgesic strategies carried out by the mother: sucking on a sugar solution, supporting non-nutritive sucking with a dummy, contact, etc.
direct voice (from 5 minutes before to 5 min after PV), wrap in a nappy and manual, and offer to grasp the finger.
Analysis of behavioural data: NFCS scores obtained from analysis of video sequences by 10 s periods (basal, per and post stimulation) by 2 blind assessors on the type of analgesia used (carer or mother).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-centre crossover study which plans t o include up to 48 newborns (objective: 40 analysable subjects, visit S and visit M carried out) for whom two different analgesic strategies will be applied, each at one of the two time points of the crossover: * a control treatment, referred to here as treatment S: standard and recommended non- pharmacological analgesic strategies carried out by the carer alone * an experimental treatment, referred to here as treatment M: overall non-pharmacological analgesic strategies carried out by the mother The groups are therefore the "order S then M" group and the "order M then S" group. The order of visits was determined randomly (prior randomisation) for each mother-child dyad.
| Arm | Type | Receives |
|---|---|---|
| premature newborns | Other | Other: Analgesic strategies during the S visit:, Other: Analgesic strategies at visit Mpremature newborns . 2 groups composed of the same children but benefiting from 2 different analgesic strategies, each applied at one of two different times. The groups compared were the "order S then M" group and the "order M then S" group. |
| premature | Other | Other: Analgesic strategies during the S visit:, Other: Analgesic strategies at visit Mpremature newborns . 2 groups composed of the same children but benefiting from 2 different analgesic strategies, each applied at one of two different times. The groups compared were the "order S then M" group and the "order M then S" group. |
Who may qualify
- Ages
- 32 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Very premature babies born before the gestational age (GA) of 32 weeks of amenorrhoea (SA) whose corrected age (CA) does not exceed 34 SA at the time of their participation.
- NN requiring close biological monitoring by a PV.
- Hospitalised in the NN medicine and intensive care unit at Strasbourg hospital.
- Consent obtained from both holders of parental authority.
- Person covered by a social health insurance scheme.
Key exclusion criteria (6 listed)
- Any known malformation affecting one or more organs.
- Cerebral lesions discovered o n cerebral ultrasound (intraventricular haemorrhage grade > 2, periventricular leukomalacia).
- Unstable clinical state as judged by the investigator and the medical team.
- Transfer to another hospital centre expected before the end of the study period.
- French.
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 |
|---|---|---|
| Analgesic strategies during the S visit:Analgesic strategies during the S visit: standard and recommended non-pharmacological analgesic strategies used by the CRI: administration of sugar solution, support for non-nutritive sucking with a dummy and wrapping in a nappy. | Other | premature, premature newborns |
| Analgesic strategies at visit MAnalgesic strategies at visit M: overall non-pharmacological analgesic strategies carried out by the mother: sucking on a sugar solution, supporting non-nutritive sucking with a dummy, contact, etc. | Other | premature, premature newborns |
Primary outcome
NFCS (Neonatal Facial Coding System)
Time frame: 7 days
the NFCS pain score assessed during a PV in two conditions: * maternal absence: "carer" analgesia (visit S) ; * maternal involvement: "mum" pain (M visit). This is a validated 4-item scale describing facial mimics in NN. The analysis was based on video sequences and blinded to the type of analgesia used. The possible score is from 0 to 4 and will be binarised to a value of "1"; the primary endpoint (PEC) is therefore the proportion of neonates with a score of "1". greater than or equal to 1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 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.
Elodie RABATEL principal investigator
Médecine et Réanimation du Nouveau-né Hôpital de Hautepierre CHU de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesic strategies during the S visit: and Analgesic strategies at visit M in people with Premature Newborns, run by University Hospital, Strasbourg, France 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie RABATEL, Nurse (+33 3 88 12 77 85, elodie.rabatel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NFCS (Neonatal Facial Coding System) (time frame: 7 days). 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 9 Jun 2026.