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
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
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