Impact of the Integrated Management of Neonatal and Childhood Illness Strategy on Neonatal and Infant Mortality
Condition: Mortality
MeSH terms: Infant Death
Study type: Interventional

Summary: 
      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:

        1. improvement in the case management skills of health staff

        2. improvement in the overall health system to support its performance, and

        3. improvement in family and community health care practices which include:

             -  prevention and management of hypothermia

             -  early initiation of breastfeeding and exclusive breastfeeding

             -  community-based care of low birth weight infants

             -  improved care-seeking for neonatal infections

      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.
    

Detailed description: 
      OBJECTIVES

      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:

        -  in reducing (i) neonatal mortality beyond the first 24 hours of birth, i.e. from 1-28
           days of age and (ii) overall neonatal mortality, i.e. from birth to 28 days of age, in
           the communities receiving the intervention [based on a cohort of infants born to women
           identified through pregnancy surveillance]

        -  in reducing (i) neonatal mortality beyond the first 24 hours of life (day 1-28) and (ii)
           overall neonatal mortality (birth to 28 days of age) in the population of newborns more
           likely to have greater impact from the intervention, i.e. those born at home and
           available in the study area within 7 days of birth [based on a cohort of infants born at
           home and available in the study area within 7 days of birth]

        -  in reducing infant mortality (from birth to 365 days of age) in the intervention
           communities [based on a cohort of infants born to women identified through pregnancy
           surveillance]

      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:

        -  20% or greater reduction in neonatal mortality.

        -  20% in the mortality of neonates beyond first 24 hours of birth.

      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):

        -  25% or greater reduction in mortality from birth to 28 days

        -  25% or greater reduction in the neonatal mortality beyond first 24 hours 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

      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:

        1. Improving the case management skills of health staff: Qualified physicians, supervisors
           and other health workers in the intervention sites along with anganwadi workers will be
           trained in IMNCI through an 8 day course. A set of information meetings will be designed
           for traditional birth attendants registered medical practitioners and qualified
           physicians working in the private sector. The training will be completed by a visit to
           the trainee at his/her work place within 1 month of the course to review the
           performance, correct any problems and support the use of the skills taught during the
           course.

        2. Strengthening of health systems.

           As part of its collaboration with the project, efforts will be undertaken by the
           District Medical Officer's team to implement the following health systems improvements
           with a focus on the intervention areas:

           Availability of drugs and supplies needed for IMNCI: In order to ensure availability of
           essential IMNCI drugs and supplies a checklist will be prepared and displayed in the
           health facility. This list will be used as a checklist during Supervisory Visits.

           Improving referral pathways and services: Facilities will keep records of cases
           attended, cases referred and problems reviewed in supervisory visits and review meetings
           between the program in charge from the local health team and different categories of
           health workers.

           Supervisory Visits: Both scheduled and unscheduled visits will be conducted by
           supervisors (belonging to the local heath system and those provided through this
           project) trained in IMNCI. Supervisors will review the availability of facility supports
           and drugs to implement IMNCI, as well as health workers performance, and provide
           feedback and help problem-solving.

        3. Improvement in family and community practices.

      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).

      OUTCOME ASCERTAINMENT

      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:

        -  Observations of health care providers, consultations with caregivers of infants aged <
           29 days and infants between 1 to 11 months of age

        -  Exit interviews with mothers who have recently visited a health care provider for
           treatment of illness in an infant aged < 29 days and infants between 1 to 11 months of
           age.

        -  Interviews with caregivers/mothers with a young infant who were home visited recently by
           a health worker

      DATA MANAGEMENT

      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.

      ANALYSIS

      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:

        -  Distance from the nearest government outpatient facility

        -  Distance from the nearest private outpatient facility

        -  Distance from the nearest government inpatient facility

        -  Distance from the nearest private inpatient facility

        -  Density of private providers

        -  Density of qualified private providers

        -  Number of private practitioners used for care of infants

      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.

      REFERENCES

        1. Smith PG, Morrow RH. Field trials of health interventions in developing countries: a
           toolbox. London: Macmillan Education, 1996

        2. Government of India. Operational Guidelines for Implementation of Integrated Management
           of Neonatal and Childhood Illness (IMNCI). Ministry of Health Family Welfare: New Delhi,
           2006.

        3. World Health Organization. Integrated Management of Childhood Illness. Geneva: World
           Health Organization, 1997 (WHO/CHD/97.3E).
    

Intervention name(s): IMNCI
Intervention type(s): Behavioral
Intervention description(s): Implementation of IMNCI in the intervention sites
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: neonatal mortality; infant mortality; newborn caring practices