Neonatal MorbidityReferral CardNCT00832143
Effect of Referral Card on Neonatal Medical Care Seeking for Institutional Births in Urban Lucknow
A study testing Referral Card with one-to-one counseling in people with Neonatal Morbidity and Neonatal Illnesses, run by King George's Medical University at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Morbidity, Neonatal Illnesses
- What is being tested?
- Referral Card with one-to-one counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates born in the participating hospital within last 48 hours and the parents on which gave written informed consent to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neonatal Morbidity, Neonatal Illnesses
- Being tested
- Referral Card with one-to-one counseling
- Keywords
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral Card with one-to-one counselingBehavioural
A Referral Card (Neonatal Well-Being Card) along with one-to-one counseling to mothers within 48 hours of institutional delivery
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual Care |
| 2 | Experimental | Referral Card with one-to-one counseling Receives: Behavioral: Referral Card with one-to-one counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The utilization of health services of qualified medical care provider (attendance; hospitalization) for neonatal sickness
Measured: In neonatal period
Secondary outcomes (1)
To assess the causes of failure of health seeking behavior for neonatal illnesses of the community
Measured: in neonatal period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- King George's Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832143
- Sponsor's protocol ID
- 819/R.Cell 04
- Other IDs
- ICMR 5/7/94/04/RHN
- Acronym
- Referral Card
- Status last verified
- Jan 2009
- First submitted
- 28 Jan 2009
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19057571
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Referral Card on Neonatal Medical Care Seeking for Institutional Births in Urban Lucknow
- ClinicalTrials.gov ID
- NCT00832143
- Acronym / sponsor ID
- Referral Card / 819/R.Cell 04
- Conditions
- Neonatal Morbidity, Neonatal Illnesses
- Keywords
- neonatal illness, qualified care seeking, Behaviour change, Urban slums, India, Neonatal morbidity, Care seeking for neonatal illnesses, Qualified medical care seeking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- King George's Medical UniversityUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual Care |
| 2 | Experimental | Behavioral: Referral Card with one-to-one counselingReferral Card with one-to-one counseling |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates born in the participating hospital within last 48 hours and the parents on which gave written informed consent to participate in the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral Card with one-to-one counselingA Referral Card (Neonatal Well-Being Card) along with one-to-one counseling to mothers within 48 hours of institutional delivery | Behavioural | 2 |
Primary outcome
The utilization of health services of qualified medical care provider (attendance; hospitalization) for neonatal sickness
Time frame: In neonatal period
1 secondary outcome
To assess the causes of failure of health seeking behavior for neonatal illnesses of the community
Time frame: in neonatal period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Results publication: PubMed 19057571Awasthi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral Card with one-to-one counseling in people with Neonatal Morbidity and Neonatal Illnesses, run by King George's Medical University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The utilization of health services of qualified medical care provider (attendance; hospitalization) for neonatal sickness (time frame: In neonatal period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00832143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009.