Condition category
Signs and Symptoms
Date applied
20/03/2009
Date assigned
30/07/2009
Last edited
10/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Judith Meek

ORCID ID

Contact details

Elizabeth Garrett Anderson Wing
University College Hospital
235 Euston Road
London
NW1 2BU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

08/0213

Study information

Scientific title

A double‐blinded randomised controlled study to assess the effect of sucrose versus sterile water on cortical responses to painful events in newborn infants

Acronym

Study hypothesis

This is a non-commercial, double-blinded randomised controlled clinical study. The primary objective is to investigate the effects of sucrose versus control (sterile water) on cortical responses to noxious events in newborn infants. The secondary objectives are to examine if sucrose administration will:
1. Induce a change of sleep state
2. Affect an immediate detectable change in blood glucose levels
3. Affect motor activity reflex responses following a noxious event, when compared to control (sterile water) treated groups.
This trial is taking place at the University College London Hospital.

Ethics approval

The Joint UCL/UCLH Committees on the Ethics of Human Research Committee Alpha, approved on 30th September 2008 (ref: 08/H0715/74)

Study design

Double-blind randomised controlled single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pain relief following an acute noxious event in newborn infants

Intervention

Subjects will be allocated at random (randomisation ratio: 1:1) to receive one of two 0.5 ml solutions onto the tongue: 24% sucrose water (Sweet-Ease®) or sterile water (control). There is a 50% chance of receiving sucrose. The treatment solution will be administered by a syringe directly into the baby's mouth approximately 2 minutes prior to the heel lance.

The sucrose and placebo will be purchased from Inspiration Healthcare, the manufacturers of Sweet-Ease®. Each recruited subject will participate in a single study and will not require a follow-up. The duration of total participation in the study will take approximately 90 minutes.

Please note that as of 11/02/10 the end date of this trial has been extended from 31/12/09 to 31/12/2010.

Intervention type

Drug

Phase

Not Specified

Drug names

Sucrose

Primary outcome measures

Cortical responses to noxious stimulation using evoked potentials (electroencephalography [EEG])

Secondary outcome measures

1. Sleep-state (EEG and video)
2. Blood glucose levels (opportunistically measured from excess blood flow)
3. Motor and facial activity (electromyogram [EMG] and video)

Overall trial start date

25/02/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. In-patients on the labour ward, post-natal ward, transitional care unit (TCU) and special care baby unit (SCBU) at the Elizabeth Garrett Anderson & Obstetrics Hospital, University College London Hospital (UCLH), UK
2. Both males and females, aged between 37 and 45 weeks post-menstrual age (PMA)
Babies will only be studied when a blood test is needed for clinical purposes.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

60

Participant exclusion criteria

Prior to each study the infant's well-being and their suitability to be studied will be assessed by the clinicians in the research group; studies will be postponed or cancelled if the infant is considered to be unfit to take part.

1. Infants who are asleep
2. Infants who are fed 30 minutes or less before the heel lance
3. Signs of tissue damage on the lower limbs
4. Intraventricular haemorrhage or periventricular leukomalacia
5. Infants who have had previous surgery
6. Infants who are receiving analgesics or sedatives
7. Infants who are born to mothers who are diabetic or opioid users
8. Infants born with congenital malformations or genetic conditions

In addition, infants that fall into the following criteria will be excluded from the study as use of 24% sucrose water is contraindicated:
9. Infants at high risk for necrotising enterocolitis
10. Asphyxiated infants
11. Infants with feeding intolerance
12. Infants without bowel sounds
13. Infants with oesophageal atresia or tracheal oesophageal fistula
14. Infants with active phase persistent pulmonary hypertension of the newborn

Recruitment start date

25/02/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Elizabeth Garrett Anderson Wing
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor type

Government

Website

http://www.uclh.nhs.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (MRC) (UK) (ref: G0502146)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20817247

Publication citations

  1. Results

    Slater R, Cornelissen L, Fabrizi L, Patten D, Yoxen J, Worley A, Boyd S, Meek J, Fitzgerald M, Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial., Lancet, 2010, 376, 9748, 1225-1232, doi: 10.1016/S0140-6736(10)61303-7.

Additional files

Editorial Notes