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Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture

RecruitingNAAges 32 Weeks - 34 WeeksAllUniversity Hospital, Strasbourg, France
NCT06200662 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 largel

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📋 Eligibility rules (as published)
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.
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What it tests

  • Analgesic strategies during the S visit:
  • Analgesic strategies at visit M
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Where

1 site
Les Hôpitaux Universitaires
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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