Pain Relief in Premature Newborns Through Maternal Intervention During Venipuncture

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Analgesic strategies at visit M: 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 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.

Eligibility

Primary outcome measure(s)

• NFCS (Neonatal Facial Coding System) — 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.

Trial sites (1)

More University Hospital, Strasbourg, France trials in France

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