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

This study has been completed.
Sponsor:
Collaborator:
Indian Council for Medical Research (ICMR), New Delhi, India
Information provided by:
King George's Medical University
ClinicalTrials.gov Identifier:
NCT00832143
First received: January 28, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention
Neonatal Morbidity
Neonatal Illnesses
Behavioral: Referral Card with one-to-one counseling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effect of Referral Card on Neonatal Medical Care Seeking for Institutional Births in Urban Lucknow

Further study details as provided by King George's Medical University:

Primary Outcome Measures:
  • The utilization of health services of qualified medical care provider (attendance; hospitalization) for neonatal sickness [ Time Frame: In neonatal period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the causes of failure of health seeking behavior for neonatal illnesses of the community [ Time Frame: in neonatal period ] [ Designated as safety issue: No ]

Enrollment: 1020
Study Start Date: March 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00832143

Locations
India
King George's Medical University
Lucknow, UP, India, 226003
Sponsors and Collaborators
King George's Medical University
Indian Council for Medical Research (ICMR), New Delhi, India
  More Information

Publications:
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
Study First Received: January 28, 2009
Last Updated: January 28, 2009
Health Authority: India: Indian Council of Medical Research

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

ClinicalTrials.gov processed this record on October 29, 2014