Condition category
Signs and Symptoms
Date applied
18/05/2015
Date assigned
21/05/2015
Last edited
26/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Premature babies (those born at less than 37 weeks gestation) usually need special care in a hospital neonatal intensive-care unit (NICU). This is because they often have serious health problems as a result of being born too early, such as difficulty with breathing and low blood sugar (glucose). As a result, premature babies often need to have an endotracheal tube inserted through their mouth and down their throat to help them breath. They also need frequent blood tests to monitor their health. Therefore, two of the most common routine procedures performed on premature babies in NICUs are suctioning of the endotracheal tube to keep the baby’s airway clear, and heel pricks to draw blood samples for glucose (blood sugar) monitoring. Both of these procedures are known to cause some level of discomfort and pain to babies, so on these occasions they are given an oral sugar (sucrose) solution and a dummy (non-nutritive sucking pacifier) to soothe them. Although these procedures are performed repeatedly in the majority of premature babies, their effect on the energy levels of the body’s cells are not clear. It is well known that if energy in the cells is low, this can lead to a lack of oxygen in blood and tissue called hypoxia. Hypoxia is known to cause pain and is a very common complication for premature babies due to them not being able to breathe on their own. The aim of this study is to see what effect suctioning of the endotracheal tube and heel prick tests have on energy levels in the cells of premature babies, and will assess the levels of hypoxia-associated pain experienced. The results of this study will be used to inform future studies investigating ways to decrease pain and hypoxia in premature babies.

Who can participate?
Premature babies of less than 36 weeks gestation.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given a sugar (sucrose) solution and a dummy during endotracheal tube suctioning and heel prick procedures. Those in group 2 (control group) are given a non-sugar solution and a dummy during endotracheal tube suctioning and heel prick procedures. Participants have blood tests and pain is assessed using a premature infant pain profile assessment tool.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
1. Loma Linda University Children's Hospital (USA)
2. Riverside County Regional Medical Center (USA)

When is the study starting and how long is it expected to run for?
February 2009 to December 2014

Who is funding the study?
National Institutes of Health (USA)

Who is the main contact?
Dr D Angeles

Trial website

www.llu.edu

Contact information

Type

Scientific

Primary contact

Dr Danilyn Angeles

ORCID ID

Contact details

Loma Linda University
Loma Linda
92354
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NR011209-01A1

Study information

Scientific title

Pain and hypoxia in premature neonates: a randomised controlled trial

Acronym

Study hypothesis

Commonly performed tissue damaging procedures exhibit a positive correlation between biobehavioural markers of pain and biochemical markers of hypoxia, oxidative stress and cell injury.

Ethics approval

Loma Linda University Institutional Review Board, 25/02/2009, ref: 59038.

Study design

Randomised double-blind placebo controlled trial design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Procedural pain in premature neonates

Intervention

1. Intervention group: sucrose 24% and non-nutritive sucking
2. Control group: placebo and non-nutritive sucking

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Pain score
2. Plasma concentration of hypoxanthine, xanthine, uric acid and allantoin

Secondary outcome measures

Not applicable.

Overall trial start date

25/02/2009

Overall trial end date

29/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Premature infants <36 weeks gestation who:
1. Weigh >800 grams
2. Have an arterial or central line catheter in place
3. Require endotracheal suctioning or heel lance

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

260

Participant exclusion criteria

1. Unstable oxygenation and hemodynamic status due to persistent pulmonary hypertension (PPHN)
2. Cyanotic heart disease
3. Severe respiratory distress
4. Septic shock
5. Taking medications such as morphine, fentanyl, versed, muscle relaxants, phenobarbital, or dilantin
6. Intraventricular hemorrhage grade 3 or more
7. Seizures
8. Facial or multiple congenital anomalies that may alter pain behavior

Recruitment start date

25/02/2009

Recruitment end date

29/12/2014

Locations

Countries of recruitment

United States of America

Trial participating centre

Loma Linda University Children's Hospital
Risley Hall
Loma Linda
92354
United States of America

Trial participating centre

Riverside County Regional Medical Center
NICU
Riverside
92354
United States of America

Sponsor information

Organisation

National Institutes of Health, National Institute of Nursing Research

Sponsor details

9000 Rockville Pike
Bethesda
Marylan
20892
United States of America

Sponsor type

Government

Website

http://nih.gov

Funders

Funder type

Government

Funder name

National Institutes of Health

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not available at time of registration.

Intention to publish date

30/06/2016

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes