Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture

NCT06200662 | Recruiting

• 1 other identifier: 8836
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Premature Newborns

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Study Arms (2)

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.

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.

Other: Analgesic strategies during the S visit:; Other: Analgesic strategies at visit M

Interventions

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.

premature; premature newborns

Analgesic strategies at visit M OTHER

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.

premature; premature newborns

Eligibility Criteria

• Age: 32 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires

Strasbourg, Bas-Rhin, 67091, France

RECRUITING

Study Officials

• Elodie RABATEL

  Médecine et Réanimation du Nouveau-né Hôpital de Hautepierre CHU de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie RABATEL, Nurse

CONTACT

+33 3 88 12 77 85; elodie.rabatel@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: January 11, 2024
• Study Start: February 22, 2024
• Primary Completion: January 7, 2026
• Study Completion: February 7, 2026
• Last Updated: July 9, 2024

Record last verified: 2023-08

Locations

FR (1)