Condition category
Neonatal Diseases
Date applied
03/11/2009
Date assigned
04/01/2010
Last edited
01/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark Tomlinson

ORCID ID

Contact details

Department of Psychology
Stellenbosch University
Private Bag X1
Matieland
7602
South Africa
Stellenbosch
7602
South Africa
markt@sun.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An effectiveness study of an integrated, community based package for maternal, newborn, child and HIV care in a disadvantaged community in South Africa

Acronym

Study hypothesis

This study aims to test the hypothesis that infants in clusters receiving a home based package of interventions, will have significantly improved HIV free survival and higher levels of exclusive appropriate feeding at 12 weeks postnatally, relative to control clusters receiving improved health facility care and key information to the mother and family on available social grants and the processes for gaining access to these grants.

Ethics approval

The Medical Research Council (South Africa) Ethics Committee approved on the 5th of May 2008 (Protocol ID: EC08-002)

Study design

Cluster randomised unblinded active controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Mother to child transmission of HIV; neonatal health

Intervention

1. Antenatal visit 1 at home
Content in this visit will include:
1.1. Antenatal care action – immunisations/micronutrient supplementation
1.2. Focus on the importance of VCT (linking this with the PMTCT programme and the benefits of testing to the mother)
1.3. Emphasise the importance of antenatal care
1.4. Key messages on appropriate infant feeding
1.5. Encourage exclusive breastfeeding in HIV negative women or women of unknown HIV status.
1.6. For HIV positive women, assist with thinking about infant feeding options
1.7. Input regarding infant communication and the mother-infant relationship

2. Antenatal visit 2 at home
Content in this visit will include:
2.1. Birth plans – place of birth, support during labour, care plans if returning to work
2.3. Danger signs and emergency plans – this will be done, if possible together with other family members in order to elicit their input regarding possible plans in the event of an emergency, including recognition of danger signs, emergency transport plan and emergency funds if needed
2.4. Homecoming arrangements
2.5. Follow up and re-emphasis on VCT, PMTCT, the key messages on appropriate infant feeding that were provided in antenatal visit 1; further discussion in terms of assisting with the implementation of chosen feeding option
2.6. Additional input on infant communication and the warning signs of postnatal depression

3. Postnatal visit 1 at home (24-48hrs)
Content in this visit will include:
3.1. Assessment of newborn– breathing, thermal care, colour, bleeding, neonatal eye care, checklist of danger signs
3.2. Assessment of mother - bleeding, signs for infection, mastitis
3.3. Early recognition of illness (superficial or systemic) and help seeking
3.4. Exclusive breastfeeding or appropriate infant feeding support
3.5. Hygienic cord care and what to expect regarding when the cord will drop off
3.6. Thermal care, skin to skin care and Kangaroo care if needed for preterm babies
3.7. Ensure that babies of HIV positive women have received Nevirapine
3.8. Information about warning signs for mother or baby and what to do
3.9. Support for women who have ‘the blues’

4. Postnatal visit 2 at home (3-4 days)
Content in this visit will include:
4.1. Assessment of the mother and the newborn, Further input on the early recognition of illness (superficial or systemic) and help seeking
4.2. Monitoring and follow up of breastfeeding or appropriate feeding and possible feeding problems
4.3. Further support for hygiene, thermal care and cord care, with Kangaroo care input if needed for preterm babies
4.4. 1st week clinic visit reminder
4.5. Information about warning signs for mother or baby and what to do
4.6. Newborn Interactive Assessment - demonstration of the abilities of infants and infant communication and social responsiveness. Sleeping, crying, consolability and wider concerns

5. Postnatal visit 3 at home (10-14 days)
Content in this visit will include:
5.1. Early recognition of illness (superficial or systemic) and help seeking
5.2. Ongoing monitoring of breastfeeding or other appropriate feeding
5.3. Information about warning signs for mother or baby and what to do
5.4. Promote attendance at clinic for 6 week visit for mother to have access to family planning and baby to receive immunisations and the babies of HIV+ women been given bactrim and HIV testing
5.5. Mother infant interaction modelling and communication input
5.6. Assess for signs of postnatal depression

6. Postnatal visit 4 at home (3-4 weeks)
Content in this visit will include:
6.1. Early recognition of illness (superficial or systemic) and help seeking
6.2. Ongoing monitoring of breastfeeding or other appropriate feeding
6.3. Information about warning signs for mother or baby and what to do
6.4. Promote attendance at clinic for 6 week visit for mother to have access to family planning and baby to receive immunisations and the babies of HIV+ women been given bactrim and HIV testing
6.5. Mother infant interaction modelling and communication input
6.6. Assess for signs of postnatal depression

7. Postnatal visit 5 at home (7-8 weeks)
Content in this visit will include:
7.1. Further input on feeding including advice regarding weaning
7.2. Infant weight from clinic card (6 week visit)
7.3. Mother infant attachment
7.4. Checklist of signs of postnatal depression
7.5. Has the child been tested for HIV at six weeks and receiving cotrimoxazole
7.6. Formula sustainability for HIV positive women using formula milk
7.7. Family planning and counselling
7.8. Input on milestones and information and specific skills about the stimulation of infants

All intervention visits will be delivered by community health workers targeting pregnant women and postnatal women and their newborns to provide essential maternal and newborn care. All visits will take place in the home

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. HIV free infant survival at 12 weeks postpartum
2. Levels of exclusive and appropriate infant feeding at 12 weeks postpartum

Secondary outcome measures

1. Better uptake of a postnatal clinic visit within 7 days of life
2. Coverage of care and behavioural indicators (antenatal HIV testing, uptake of cotrimoxazole amongst HIV exposed infants at 6 weeks, family planning uptake at 6 weeks)
3. Levels of maternal depression at 12 weeks postpartum
4. To assess whether the intervention is cost-effective compared to improved health facility care alone. This will be evaluated in terms of cost per HIV infection averted and disability-adjusted life years (DALY’s) saved

Overall trial start date

17/06/2008

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All pregnant women aged 16-49 years who give informed consent for study participation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

A total of 3600 pregnant women will be recruited

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

17/06/2008

Recruitment end date

31/10/2010

Locations

Countries of recruitment

South Africa

Trial participating centre

Department of Psychology
Stellenbosch
7602
South Africa

Sponsor information

Organisation

Saving Newborn Lives (Save the Children) (USA)

Sponsor details

2000 L Street NW
Suite 500
Washington
DC 20036
Washington
20036
United States of America
joylawn@yahoo.co.uk

Sponsor type

Charity

Website

http://www.savethechildren.org

Funders

Funder type

Other

Funder name

Center for Disease Control (CDC) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Saving Newborn Lives (Save the Children) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Health Organization (WHO)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

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

1. 2011 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22044553
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23388385

Publication citations

  1. Study protocol

    Tomlinson M, Doherty T, Jackson D, Lawn JE, Ijumba P, Colvin M, Nkonki L, Daviaud E, Goga A, Sanders D, Lombard C, Persson LÅ, Ndaba T, Snetro G, Chopra M, An effectiveness study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa: study protocol for a randomized controlled trial., Trials, 2011, 12, 236, doi: 10.1186/1745-6215-12-236.

  2. Results

    Nsibande D, Doherty T, Ijumba P, Tomlinson M, Jackson D, Sanders D, Lawn J, Assessment of the uptake of neonatal and young infant referrals by community health workers to public health facilities in an urban informal settlement, KwaZulu-Natal, South Africa., BMC Health Serv Res, 2013, 13, 47, doi: 10.1186/1472-6963-13-47.

Additional files

Editorial Notes