Parental Touch Trial (Petal)

Paediatric Neuroimaging Research Group

Status: Completed

Conditions: Parents; Infant Development; Pain, Procedural

Treatments: Behavioral: Parental touch

Study type: Interventional

Funder types: Other

Identifiers

NCT04901611

Petal

Details and patient eligibility

About

This is a two centre two-arm randomised controlled interventional trial. We aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia in neonates.

Full description

This is a multicentre randomised-controlled interventional trial, with two research sites (John Radcliffe Hospital, Oxford, and Royal Devon and Royal Devon and Exeter Hospital, Devon). In this study we aim to determine whether parental touch prior to a painful clinical procedure provides effective analgesia.

The primary objective is to determine whether parental touch reduces noxious-evoked brain activity following a heel lance. In addition, our secondary and exploratory objectives include investigating the effect of touch on behavioural and electrophysiological measures evoked by a heel lance. Neonates will be randomised to receive parental touch either prior to or post a clinically required heel lance. We will also investigate how parental touch impacts post-procedural clinical stability and explore whether this intervention affects parental anxiety.

Neonates will be recruited during a 9-month period. Participants will be studied on a single test occasion while they are in hospital, when they require a clinical heel lance. No extra blood tests or noxious procedures will be performed for the purpose of the study. Participants will be included in the study for approximately an hour period. This will be approximately 30 min before and after the time when the heel lance is performed. Individual babies will only be included in the trial once. If a neonate requires additional heel lances to acquire sufficient blood for clinical assessment at the time of the test occasion, we will also record the responses to this.

Enrollment: 112 patients

Sex: All

Ages: Under 7 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants born at the John Radcliffe Hospital, Oxford or the Royal Devon and Exeter Hospital, Devon
• Neonates born at or after 35+0 weeks gestation
• Neonates with a postnatal age of 7 days or less
• Neonates who clinically require a heel lance
• Neonates for whom parents/guardians have given written informed consent for inclusion in the trial

Exclusion criteria

• Intraventricular haemorrhage (IVH) > grade II
• Received any analgesics or sedatives in the last 24 hours
• Congenital malformation or genetic condition known to affect neurological development
• Born to mothers who have a history of substance abuse.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups, including a placebo group

Parental touch (pre-procedural)

Experimental group

Description:

Parents will stroke their baby on the posterior lower limb of the leg where the heel lance will be administered, at a speed of 3cm/s for 10 seconds using the whole hand and in one direction down the limb towards the foot. This will happen just before the control procedure and clinical heel lance.

Treatment:

Behavioral: Parental touch

Parental touch (post-procedural)

Placebo Comparator group

Description:

Parents will stroke their baby on the posterior lower limb of the leg where the heel lance was administered, at a speed of 3cm/s for 10 seconds using the whole hand and in one direction down the limb towards the foot. This will happen just after the control procedure and clinical heel lance.

Treatment:

Behavioral: Parental touch