NCT04901611

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

May 13, 2021

Last Update Submit

February 27, 2023

Conditions

Infant DevelopmentPain, ProceduralParents

Keywords

Parental touchBrain activityStrokingAnxietyClinical pain scoreHeart rateRespiratory rate

Outcome Measures

Primary Outcomes (1)

  • Magnitude of noxious-evoked brain activity

    An electroencephalography (EEG) template based on the Principal Component that reflects the noxious-evoked brain activity in neonates has been defined and validated in independent data sets (Hartley 2017). This template will be projected onto the EEG data recorded in the 1000ms period following each heel lance and heel lance control stimulus and the relative weight of the component calculated for each neonate. A greater weight indicates a stronger noxious-evoked response.

    Immediately after heel lance (within 1000ms)

Secondary Outcomes (3)

  • Premature Infant Pain Profile - Revised score (PIPP-R score)

    During the 30s period after the heel lance

  • Percentage of neonates who develop tachycardia

    During the 30s period after the heel lance

  • Parental anxiety

    At the end of the test occasion, within 30 minutes of the heel lance

Other Outcomes (4)

  • Exploratory outcome: changes in brain activity during parental touch intervention

    During parental touch intervention

  • Exploratory outcome: time taken for heart rate to return to baseline post-heel lance

    30 min time period after the clinical heel lance

  • Exploratory outcome: post-procedural variability in respiratory rate, incidence of apnoea, and change in respiratory stability

    30 min time period after the clinical heel lance

  • +1 more other outcomes

Study Arms (2)

Parental touch (pre-procedural)

EXPERIMENTAL

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.

Behavioral: Parental touch

Parental touch (post-procedural)

PLACEBO COMPARATOR

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.

Behavioral: Parental touch

Interventions

Parental touchBEHAVIORAL

Parental touch in the form of stroking at 3cm/s for 10 seconds on the posterior lower limb where the heel lance will be/has been administered

Parental touch (post-procedural)Parental touch (pre-procedural)

Eligibility Criteria

Age0 Days - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (4)

  • Baxter L, Hauck AGV, Bhatt A, Cobo MM, Hartley C, Marchant S, Poorun R, van der Vaart M, Slater R. Statistical analysis plan for the Petal trial: the effects of parental touch on relieving acute procedural pain in neonates. Wellcome Open Res. 2024 Dec 18;8:402. doi: 10.12688/wellcomeopenres.19819.3. eCollection 2023.

    PMID: 40110538DERIVED

  • Hauck AGV, van der Vaart M, Adams E, Baxter L, Bhatt A, Crankshaw D, Dhami A, Evans Fry R, Freire MBO, Hartley C, Mansfield RC, Marchant S, Monk V, Moultrie F, Peck M, Robinson S, Yong J, Poorun R, Cobo MM, Slater R. Effect of parental touch on relieving acute procedural pain in neonates and parental anxiety (Petal): a multicentre, randomised controlled trial in the UK. Lancet Child Adolesc Health. 2024 Apr;8(4):259-269. doi: 10.1016/S2352-4642(23)00340-1. Epub 2024 Feb 16.

    PMID: 38373429DERIVED

  • van der Vaart M, Hauck AGV, Mansfield R, Adams E, Bhatt A, Cobo MM, Crankshaw D, Dhami A, Hartley C, Monk V, Evans Fry R, Moultrie F, Robinson S, Yong J, Poorun R, Baxter L, Slater R. Parental experience of neonatal pain research while participating in the Parental touch trial (Petal). Pain. 2024 Aug 1;165(8):1727-1734. doi: 10.1097/j.pain.0000000000003177. Epub 2024 Jan 25.

    PMID: 38284396DERIVED

  • Cobo MM, Moultrie F, Hauck AGV, Crankshaw D, Monk V, Hartley C, Evans Fry R, Robinson S, van der Vaart M, Baxter L, Adams E, Poorun R, Bhatt A, Slater R. Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal). BMJ Open. 2022 Jul 19;12(7):e061841. doi: 10.1136/bmjopen-2022-061841.

    PMID: 36250332DERIVED

MeSH Terms

Conditions

Pain, ProceduralAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Eleri Adams

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

  • Ravi Poorun

    Royal Devon and Exeter NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Paediatric Neuroscience

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 25, 2021

Study Start

September 1, 2021

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

The data that support the findings of this study are available from the PI (rebeccah.slater@paediatrics.ox.ac.uk) listed on clinicaltrials.gov. The Study Protocol, Informed Consent Form and Statistical Analysis Plan will be available to download as a supplement to the final publication of the results.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Available after the publication of final results.
Access Criteria
PI will have discretion to share data with potential collaborators.

Locations

GB(1)