NCT00832143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,020

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

January 28, 2009

Last Update Submit

January 28, 2009

Conditions

Keywords

neonatal illnessqualified care seekingBehaviour changeUrban slumsIndiaNeonatal morbidityCare seeking for neonatal illnessesQualified medical care seekingIntegrated management of neonatal and childhood illnesses (IMNCI)

Outcome Measures

Primary Outcomes (1)

  • The utilization of health services of qualified medical care provider (attendance; hospitalization) for neonatal sickness

    In neonatal period

Secondary Outcomes (1)

  • To assess the causes of failure of health seeking behavior for neonatal illnesses of the community

    in neonatal period

Study Arms (2)

1

NO INTERVENTION

Usual Care

2

EXPERIMENTAL

Referral Card with one-to-one counseling

Behavioral: Referral Card with one-to-one counseling

Interventions

A Referral Card (Neonatal Well-Being Card) along with one-to-one counseling to mothers within 48 hours of institutional delivery

2

Eligibility Criteria

AgeUp to 4 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King George's Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Related 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 29, 2009

Study Start

March 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations