Welcome
Support Centre
26 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Improving neonatal outcomes by training nurses in Brazil
ISRCTN ISRCTN83110114
DOI 10.1186/ISRCTN83110114
ClinicalTrials.gov identifier
EudraCT number
Public title Improving neonatal outcomes by training nurses in Brazil
Scientific title Improving neonatal outcomes by training nurses in Brazil: a non-randomised trial
Acronym N/A
Serial number at source NA
Study hypothesis Studies carried out by the applicants in 6 NICUs in Rio since 2004, as well as routine data show that:
1. Mortality among VLBW babies in Rio is 32%
2. Rates of BPD reported by the local neonatology network are 11.3%
3. Sepsis rates in VLBW babies are also very high at > 60%
4. Rates of severe ROP in VLBW babies vary from 3.7 -12.5% being much higher than in industrialized countries
5. Poor nutritional status is common
6. Equipment for monitoring oxygen is often inadequate, or not optimally used
7. Nurses are often unaware of their critical role in reducing mortality and complications
8. The ratio nurses/baby was below the nationally recommended level for Brazil (1 nurse for 2 babies), ranging from 1:2 in only one unit to 1:17 in another

These findings suggest that much can be done at relatively low cost to reduce mortality and the complications of prematurity, by training nurses and increasing equipment for monitoring oxygen saturation levels.

Training nursing staff who care for preamature babies in neonatal units in Brazil and providing additional supervisory support and minimum essential equipment will improve a range of outcomes of neonatal intensive care.
Lay summary Background and study aims
Prematurity is defined as a gestation of <37 completed weeks, and low Birth Weight (BW) as <2,500g. Very preterm infants are <32 weeks gestation and Very Low BW (VLBW) <1500g. VLBW babies have much higher mortality rates than full term babies, and prematurity can lead to serious complications with life-long implications. These include Retinopathy of prematurity (ROP), which can lead to irreversible blindness; broncho-pulmonary dysplasia (BPD), a form of chronic lung disease; serious infection and infection of the gut (necrotising enterocolitis) which can cause death or other long term problems. Many VLBW babies also fail to grow and gain weight which adversely affects their development. Mortality rates among VLBW babies vary, ranging from >45% in NICUs in low and middle income countries to less than 10% in industrialized countries. Good organization and management of care are critical factors influencing the outcome of neonatal care, and rigorous adherence to protocols has been shown to improve outcomes in India.

Who can participate?
Premature babies (<1500 gs or <34 weeks gestational age) cared for in neonatal intensive care units in Rio de Janeiro, Brazil.

What does the study involve?
1. An educational package offered to all nurses in each participating neonatal unit
2. Provision of minimal essential equipment e.g. for monitoring oxygen in each unit according to need

The comparison will be before and after delivering the intervention.

What are the possible benefits and risks of participating?
If the intervention improves nursing care, then this will lead to fewer complications and lower mortality. There are no side effects.

Where is the study run from?
Six neonatal units in Rio de Janeiro

When is the study starting and how long is it expected to run for?
From March 2008 to end of 2011

Who is funding the study?
Swiss foundation

Who is the main contact?
Professor Clare Gilbert
clare.gilbert@lshtm.ac.uk
Ethics approval Ethics Committee of the London School of Hygiene and Tropical Medicine approved on 4th September 2007, ref 5195. Amended to allow qualitative research to explore reasons behind the findings: A228/5195, 4th February 2011
Study design Non-randomised trial with before and after measures
Countries of recruitment Brazil
Disease/condition/study domain Preterm babies
Participants - inclusion criteria 1. Premature babies in seven neonatal intensive care units in Rio de Janeiro Brazil
2. Babies weighing < 1500gs at birth who were inborn in these units
Participants - exclusion criteria 1. Birth weight 1,500g or more
2. Major congenital abnormalities
Anticipated start date 01/01/2007
Anticipated end date 31/12/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 800-900 in the seven units overall; 400-450 in each of the years before and after the POINTS of Care intervention
Interventions The intervention was developed with the nursing staff and with the input of local neonatology colleagues, and was an interactive process so that the training materials and approach was the most appropriate for the setting. The interventions consisted of:
1. Six self taught modules covering the following:
1.1. Pain control
1.2. Oxygen control
1.3. Infection control
1.4. Nutrition
1.5. Temperature control
1.6. Supportive care e.g. kangaroo care
2. Each of the six elements were supported by a DVD which demonstrated aspects of the training materials
3. A before and after self assessment, to encourage learning
4. Training and support of two nurse trainers
5. Provision of minimum essential equipment e.g. probes for oximeters. Each unit created a list of equipment which was ordered (Note: The equipments unfortunately did not arrive in time)
Primary outcome measure(s) Rates of retinopathy of prematurity defined as ROP severe enough to warrant treatment
Secondary outcome measure(s) 1. Mortality rates, by birthweight group
2. Sepsis within 48 hours of birth and after 48 hours
3. Bronchopulmonary dysplasia, defined as requiring oxygen at 28 days after birth and on oxygen at 36 weeks postmenstrual age
4. Necrotising enterocolitis
Sources of funding Swiss Foundation (Switzerland)
Trial website
Publications
Contact name Prof  Clare  Gilbert
  Address International Centre for Eye Health
Clinical Research Department
London School of Hygiene and Tropical Medicine
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Tel +44 (0)20 7958 8332
  Fax +44 (0)20 7958 8325
  Email clare.gilbert@lshtm.ac.uk
Sponsor London School of Hygiene and Tropical Medicine (UK)
  Address c/o Penny Ireland
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Tel + 44 (0)20 7927 2678
  Email penny.ireland@lshtm.ac.uk
  Sponsor website: http://www.lshtm.ac.uk
Date applied 09/11/2011
Last edited 18/01/2012
Date ISRCTN assigned 05/12/2011
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.