Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality (IMNCI-India)
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|ClinicalTrials.gov Identifier: NCT00474981|
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : April 3, 2012
|First Submitted Date ICMJE||May 16, 2007|
|First Posted Date ICMJE||May 17, 2007|
|Last Update Posted Date||April 3, 2012|
|Start Date ICMJE||June 2006|
|Primary Completion Date||April 2010 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00474981 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality|
|Official Title ICMJE||Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality in Haryana, India|
This study is a cluster-randomized trial being conducted in the state of Haryana in North India. Eighteen geographical areas served by Primary Health Centres (PHCs) have been randomized to intervention or comparison areas. In the intervention areas, all physicians, health workers and ICDS workers are being trained in the IMNCI. Each of these clusters has an approximate population of 30,000.
The IMNCI intervention includes three main components:
The primary outcome measures of the study are neonatal and infant mortality. The study will also collect information on cause-specific neonatal mortality, ascertained using a standardized previously validated verbal autopsy instrument administered by trained, skilled health workers. All the other outcomes (including initiation of breastfeeding within 1 hour of birth; Exclusive breastfeeding at 4 weeks of age; Proportion of neonates identified to be sick by caregivers who sought care) are secondary outcomes.
The effectiveness of this comprehensive intervention will be measured by comparing the primary and secondary outcome measures in the intervention and comparison clusters, controlling for any baseline differences such as the predefined outcomes and/or socioeconomic status and demography.
The project will serve as a guide to the Government of India of how to best implement the IMNCI strategy and measure its impact.
The primary objective of this study is to determine the effectiveness of delivering community and facility based newborn interventions as part of the IMNCI strategy:
The secondary objectives of the study are to determine the effectiveness of delivering community and facility based newborn interventions as part of the IMNCI strategy:
- in improving newborn care practices in households.
SAMPLE SIZE ESTIMATES
Sample size estimates were revised subsequent to the expansion of the primary objectives and completion of one year of surveillance.
Cohort identified through pregnancy surveillance: The average neonatal mortality rate in the 18 sites in the first year of the study was 42 (range 31-52 ) in the cohort of infants born to women identified through pregnancy surveillance .The neonatal mortality rate beyond the first 24 hours of birth in the same cohort was 24 (range 19-31). We estimated that on an average 3700 neonates per cluster would be enrolled over the study enrollment period of 27 months after taking into account 10% attrition, to detect 20% difference in mortality with 80% power and 95% confidence level.
Population more likely to have greater impact from the intervention: The average neonatal mortality rate in the target population of newborns who are more likely to benefit from the intervention i.e. those born at home and available in study area within 7 days of birth was 36 (range 19-43). The mortality beyond the first 24 hours of birth in the same cohort was 22 (range 13-25). On an average 2000 neonates per cluster would be enrolled over the study enrollment period of 27 months. This would enable us to detect 25% difference in mortality with 80% power and 95% confidence level.
To summarise, 27 months of enrollment will give 80% or more power to detect:
In the pregnancy cohort:
In the population more likely to have greater impact (i.e. those born at home and available in the study area within 7 days of birth):
The sample size has also been estimated for process evaluation outcomes through observations at health facilities (quality of care at health facilities) and exit interviews (knowledge and skills of mothers on home care of illness). Our guesstimates of the proportions in the control group are based on experience of working in the area. The number of clusters was taken as 9 per group based on sample size calculations for mortality discussed above. The table below shows that 50 observations and 50 exit interviews per cluster (i.e. 450 observations and exit interviews each in the intervention clusters and 450 in the control clusters i.e. a total of 1800) would be adequate to detect a 20% absolute increase in the outcome with 90% power.
The intervention was designed following the guidelines developed by the Government of India in collaboration with the WHO and UNICEF (2). The intervention includes three main components:
The aim of this component of the IMNCI strategy is to initiate, reinforce and sustain the key family practices for child survival, growth and development. Practices that are of particular importance for newborn health (early initiation of breastfeeding and avoidance of pre-lacteal feeds; keeping the baby warm, avoiding early bathing, cord hygiene, care seeking for danger signs and special attention for LBW newborns) will be promoted in addition to the standard IMCI key practices (3).
One field worker will be allocated 2000 to 3000 households and will keep his/her area under surveillance to identify pregnant women. For all pregnancies identified, visits will be made to the household on a day coinciding with infant age ~1 month to document the outcome of pregnancy. Subsequent visits will be made at infant age 3, 6, 9 and 12 months to record the vital status of the infant.
PROCESS EVALUATION ACTIVITIES
These will be conducted by a 6 member team both in the intervention and control clusters and will essentially focus on activities that ascertain how well the intervention is being implemented. The evaluation will be conducted in a small subsample of the various activities in each of the 18 clusters and will include the following:
Forms filled in the field will be manually self-checked for missing information, data range and consistency by the person filling the form. A double data entry system will be used followed by validation and merging of the double entered cleaned data.
Socioeconomic, environmental and demographic characteristics of the intervention and control clusters will be examined for group comparability. Any significant differences will be controlled for during data analysis. The potential confounders on which data will be collected at baseline include:
The frequencies of the main study variables will be examined to assess the distribution of data. If the data are not normally distributed, decisions about the need for data transformation and the appropriateness of statistical tests will be made.
Efficacy evaluation will be done by comparing the primary and secondary outcome measures in the intervention and control clusters, controlling for any socioeconomic, environmental or demographic differences.
To account for the clustered nature of the data, techniques such as Generalized Estimating Equation and multi-level modelling will be used.
Data analysis will be carried out using Stata, Version 8.2.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
|Intervention ICMJE||Behavioral: IMNCI
Implementation of IMNCI in the intervention sites
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||April 2010|
|Primary Completion Date||April 2010 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||up to 12 Months (Child)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||India|
|Removed Location Countries|
|NCT Number ICMJE||NCT00474981|
|Other Study ID Numbers ICMJE||C6-181-505|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||NBhandari, Society for Applied Studies|
|Study Sponsor ICMJE||Society for Applied Studies|
|PRS Account||Society for Applied Studies|
|Verification Date||April 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP