Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal)

Abstract

IntroductionNewborn infants routinely undergo minor painful procedures as part of postnatal care, with infants born sick or premature requiring a greater number of procedures. As pain in early life can have long-term neurodevelopmental consequences and lead to parental anxiety and future avoidance of interventions, effective pain management is essential. Non-pharmacological comfort measures such as breastfeeding, swaddling and sweet solutions are inconsistently implemented and are not always practical or effective in reducing the transmission of noxious input to the brain. Stroking of the skin can activate C-tactile fibres and reduce pain, and therefore could provide a simple and safe parent-led intervention for the management of pain. The trial aim is to determine whether parental touch prior to a painful clinical procedure provides effective pain relief in neonates.Methods and analysisThis is a multicentre randomised controlled trial. A total of 112 neonates born at 35 weeks’ gestation or more requiring a blood test in the first week of life will be recruited and randomised to receive parental stroking either preprocedure or postprocedure. We will record brain activity (EEG), cardiac and respiratory dynamics, oxygen saturation and facial expression to provide proxy pain outcome measures. The primary outcome will be the reduction of noxious-evoked brain activity in response to a heel lance. Secondary outcomes will be a reduction in clinical pain scores (Premature Infant Pain Profile-Revised), postprocedural tachycardia and parental anxiety.Ethics and disseminationThe study has been approved by the London—South East Research Ethics Committee (ref: 21/LO/0523). The results will be widely disseminated through peer-reviewed publications, international conferences and via our partner neonatal charities Bliss and Supporting the Sick Newborn And their Parents (SSNAP). If the parental tactile intervention is effective, recommendations will be submitted via the National Health Service clinical guideline adoption process.Study statusCommenced September 2021.Trial registration numberNCT04901611; 14 135 962.

The PiNe box: Development and validation of an electronic device to time-lock multimodal responses to sensory stimuli in hospitalised infants

“…Moreover, multimodal recordings of responses to noxious stimuli are essential to adequately assess the efficacy and safety of analgesics in randomised controlled trials [ 24 ] and easy-to-use acquisition methods which can work seamlessly alongside hospital monitoring devices will facilitate this [ 26 ]. The PiNe box is currently being used in the Petal randomised controlled trial assessing the benefits of parental touch for relieving pain in newborn infants [ 27 ], which provides a direct example of how this system can be used to easily acquire multimodal recordings in a clinical trial. In response to a clinically-required heel lance, the single infant shown in this paper has a clear physiological and neurophysiological response, including an increase in heart rate and an evoked potential in the EEG recording characterised well by the previously described and validated template of noxious-evoked brain activity [ 16 ].…”

Is noxious stimulus-evoked electroencephalography response a reliable, valid, and interpretable outcome measure to assess analgesic efficacy in neonates? A systematic review and individual participant data (IPD) meta-analysis protocol

“…The magnitude of this positive de ection can be quanti ed using a standardized waveform that is scaled to the amplitude of the evoked signal [10] using linear regression. This can be used to study the in uence of analgesic interventions on the magnitude of noxious stimulus-evoked brain activity in randomised clinical trials [11,12]. We suggest that this speci c EEG metric of noxious stimulus-evoked brain activity can provide a reliable, valid, and interpretable proxy measure of neonatal pain that is not behaviour-, autonomic-, or haemodynamic-based.…”

Parent-led neonatal pain management—a narrative review and update of research and practices

“…The aim of SWEpap is to investigate parents' and nurses' reflections on experiencing parent-delivered pain management, breastfeeding (when applicable), skin-to-skin contact, and parental infant-directed lullaby singing, during painful procedures in neonatal care. Another on-going study, the British Petal Trial, is examining the pain-relieving effects of parental touching, or more specific strokes in 112 neonates undergoing heel lancing on noxious-evoked brain activity, pain scores, parental anxiety, and parents' reflections on participating in neonatal pain research ( 119 , 120 ).…”