ISRCTN ISRCTN49512764
DOI https://doi.org/10.1186/ISRCTN49512764
Secondary identifying numbers NR011209-01A1
Submission date
18/05/2015
Registration date
21/05/2015
Last edited
26/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Study website

Contact information

Dr Danilyn Angeles
Scientific

Loma Linda University
Loma Linda
92354
United States of America

Study information

Study designRandomised double-blind placebo controlled trial design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titlePain and hypoxia in premature neonates: a randomised controlled trial
Study objectivesCommonly 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(s)Loma Linda University Institutional Review Board, 25/02/2009, ref: 59038.
Health condition(s) or problem(s) studiedProcedural pain in premature neonates
Intervention1. Intervention group: sucrose 24% and non-nutritive sucking
2. Control group: placebo and non-nutritive sucking
Intervention typeSupplement
Primary outcome measure1. Pain score
2. Plasma concentration of hypoxanthine, xanthine, uric acid and allantoin
Secondary outcome measuresNot applicable.
Overall study start date25/02/2009
Completion date29/12/2014

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants260
Key inclusion criteriaPremature 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
Key exclusion criteria1. 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
Date of first enrolment25/02/2009
Date of final enrolment29/12/2014

Locations

Countries of recruitment

  • United States of America

Study participating centres

Loma Linda University Children's Hospital
Risley Hall
Loma Linda
92354
United States of America
Riverside County Regional Medical Center
NICU
Riverside
92354
United States of America

Sponsor information

National Institutes of Health, National Institute of Nursing Research
Government

9000 Rockville Pike
Bethesda, Marylan
20892
United States of America

Website http://nih.gov
ROR logo "ROR" https://ror.org/01y3zfr79

Funders

Funder type

Government

National Institutes of Health
Government organisation / National government
Alternative name(s)
Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location
United States of America

Results and Publications

Intention to publish date30/06/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planNot available at time of registration.
IPD sharing plan