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Effect of Referral Card on Neonatal Medical Care Seeking for Institutional Births in Urban Lucknow (Referral Card)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00832143
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : January 29, 2009
Information provided by:

Study Description
Brief Summary:

Neonatal mortality rate in Uttar Pradesh, Northern India is 53.6 per thousand, and accounts for 8% of global neonatal deaths.It has been argued that prompt and appropriate care-seeking for sick neonates can substantially reduce neonatal mortality. This pre and post intervention trial was done to assess the impact of a pictorial "Neonatal referral Card" and one-to-one counseling of mothers on the qualified medical care-seeking behavior for sick neonates in urban Lucknow.

The study hypothesis was that the counseling on danger signs along with neonatal referral card has no impact on availing services of a qualified medical practitioner by caregivers of sick neonates.

Condition or disease Intervention/treatment
Neonatal Morbidity Neonatal Illnesses Behavioral: Referral Card with one-to-one counseling

Detailed Description:
The study was conducted in two government maternity hospitals in Lucknow. Neonates enrolled in the pre intervention phase were followed up for 6 weeks+15 days but did not recieve the study intervention. While, the mothers of the neonates enrolled in the post intervention phase recieved the study intervention within 48 hours of institutional delivery.Enrollment and follow-up procedures were same in both the phases.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1020 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Referral Card on Neonatal Medical Care Seeking for Institutional Births in Urban Lucknow
Study Start Date : March 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008
Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
Usual Care
Experimental: 2
Referral Card with one-to-one counseling
Behavioral: Referral Card with one-to-one counseling
A Referral Card (Neonatal Well-Being Card) along with one-to-one counseling to mothers within 48 hours of institutional delivery

Outcome Measures

Primary Outcome Measures :
  1. The utilization of health services of qualified medical care provider (attendance; hospitalization) for neonatal sickness [ Time Frame: In neonatal period ]

Secondary Outcome Measures :
  1. To assess the causes of failure of health seeking behavior for neonatal illnesses of the community [ Time Frame: in neonatal period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Neonates born in the participating hospital within last 48 hours and the parents on which gave written informed consent to participate in the study.

Exclusion Criteria:

  • Neonates presenting with any clinically detectable congenital malformation at birth or who required any resuscitation at birth or who were admitted for any morbidity immediately after birth or those who were not the residents of Lucknow or were likely to leave the city limits within next one month.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832143

King George's Medical University
Lucknow, UP, India, 226003
Sponsors and Collaborators
King George's Medical University
Indian Council of Medical Research
More Information

Responsible Party: Prof Shally Awasthi, Chattrapati Shahuji Maharaj Medical University
ClinicalTrials.gov Identifier: NCT00832143     History of Changes
Other Study ID Numbers: 819/R.Cell 04
ICMR 5/7/94/04/RHN
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

Keywords provided by King George's Medical University:
neonatal illness
qualified care seeking
Behaviour change
Urban slums
Neonatal morbidity
Care seeking for neonatal illnesses
Qualified medical care seeking
Integrated management of neonatal and childhood illnesses (IMNCI)