Condition category
Pregnancy and Childbirth
Date applied
09/11/2011
Date assigned
05/12/2011
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Clare Gilbert

ORCID ID

Contact details

International Centre for Eye Health
Clinical Research Department
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7958 8332
clare.gilbert@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NA

Study information

Scientific title

Improving neonatal outcomes by training nurses in Brazil: a non-randomised trial

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Preterm babies

Intervention

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)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rates of retinopathy of prematurity defined as ROP severe enough to warrant treatment

Secondary outcome measures

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

Overall trial start date

01/01/2007

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

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

Participant exclusion criteria

1. Birth weight 1,500g or more
2. Major congenital abnormalities

Recruitment start date

01/01/2007

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Brazil

Trial participating centre

International Centre for Eye Health
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

c/o Penny Ireland
Keppel Street
London
WC1E 7HT
United Kingdom
+ 44 (0)20 7927 2678
penny.ireland@lshtm.ac.uk

Sponsor type

University/education

Website

http://www.lshtm.ac.uk

Funders

Funder type

Government

Funder name

Swiss Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes