Pain relief for premature newborns during blood draws through maternal support
Official title: Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture: Effectiveness, Experiences of Parents and Carers
Run by University Hospital, Strasbourg, France · NCT06200662 · Data updated 2026-11-12
This study is testing if having mothers support their extremely premature newborns during blood draws can help reduce pain and improve their well-being compared to standard pain relief methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 32 Weeks to 34 Weeks |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg, Bas-Rhin) |
| Status | Recruiting |
| Started | February 22, 2024 |
| Main results expected | January 7, 2028 |
| Study ends | February 7, 2028 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT06200662 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are very premature newborns born before 32 weeks of gestational age who require venipuncture for close biological monitoring.
✕Probably not a fit
Patients with known organ malformations, severe cerebral lesions, or unstable clinical states may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial focuses on providing pain relief to extremely premature newborns during venipuncture by utilizing maternal interventions. The study involves a randomized approach where newborns receive either standard non-pharmacological analgesic strategies or maternal support techniques during the procedure. Behavioral data will be collected through video analysis to assess the effectiveness of the different analgesic strategies. The aim is to improve the well-being and neurological development of these vulnerable infants by minimizing pain during necessary medical procedures.
Why it matters
Potential benefit: If successful, this approach could significantly enhance pain management for premature newborns, leading to better long-term neurological outcomes.
How similar studies have gone: Other studies have shown promising results with non-pharmacological pain relief strategies in neonates, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Les Hôpitaux Universitaires
Strasbourg, Bas-Rhin, France Recruiting
Study contacts
- Principal investigator: Elodie RABATEL — Médecine et Réanimation du Nouveau-né Hôpital de Hautepierre CHU de Strasbourg
- Study coordinator: Elodie RABATEL, Nurse
- Email: elodie.rabatel@chru-strasbourg.fr
- Phone: +33 3 88 12 77 85
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.