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

Neonatal Morbidity Clinical Trial

— Referral Card  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832143
• Other study ID #: 819/R.Cell 04
• Secondary ID: ICMR 5/7/94/04/R
• Status: Completed
• Phase: N/A
• First received: January 28, 2009
• Last updated: January 28, 2009
• Start date: March 2007
• Est. completion date: June 2008

Study information

• Verified date: January 2009
• Source: King George's Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1020
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Neonatal Illnesses
• Neonatal Morbidity

Intervention

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

Locations

Country	Name	City	State
India	King George's Medical University	Lucknow	UP

Sponsors (2)

Lead Sponsor	Collaborator
King George's Medical University	Indian Council for Medical Research (ICMR), New Delhi, India

Country where clinical trial is conducted

India, 

References & Publications (1)

Awasthi S, Srivastava NM, Pant S. Symptom-specific care-seeking behavior for sick neonates among urban poor in Lucknow, Northern India. J Perinatol. 2008 Dec;28 Suppl 2:S69-75. doi: 10.1038/jp.2008.169. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The utilization of health services of qualified medical care provider (attendance; hospitalization) for neonatal sickness		In neonatal period	No
Secondary	To assess the causes of failure of health seeking behavior for neonatal illnesses of the community		in neonatal period	No