Nepal Clean Home Delivery Kit: Evaluation of the Health Impact - Path

encompassing the target number of wards was selected. All wards within the selected
VDCs were canvassed regularly throughout the data collection period to identify all
eligible births until the requisite number of births in each of the four study blocks was
enrolled. Publicity campaigns and discounts to distributors were used to increase the sale
of kits in the selected study areas to ensure full enrollment of births involving kit use.
Participants and Sample Size
Eligible participants included all women in the study sites who delivered a live infant
(who survived at least 24 hours after birth), born at home between 7 and 28 days prior to
interview. Information on the newborn’s health status was obtained from other significant
caregivers in the household, where applicable; information on delivery practices was
obtained from others present at the delivery, where possible. Mothers were enrolled in
one of four possible cohorts: kit user with trained attendant, kit user with untrained or no
attendant, kit non-user with trained attendant, and kit non-user with untrained or no
attendant. Eligible households were identified by runners, who visited assigned wards on
a regular schedule to inquire from health workers, community health volunteers, TBAs,
and other relevant community members about any new births. Visits of the interviewers
to identified eligible households were coordinated closely with the runners to ensure the
minimum delay in completing interviews with identified households.
Based on an estimated incidence of cord infection in 10-12% of births, the sample size
required to test the hypothesis that kit use reduced cord infection by at least 50% is 400
newborns in each cohort (with a one-sided 95% confidence interval and 80% power). The
expected number of neonatal deaths in each cohort would be about 20, so it would be
unlikely that a noticeable reduction in mortality due to infection could be observed or
documented.
Data Collection
Six teams, consisting of a female interviewer and a male runner in each, were recruited in
Kathmandu to collect the data. Data were collected by interviews with mothers of
newborns, with members of the mother’s household who were present for the delivery or
were caretakers of the newborn, and with some trained TBAs who participated in eligible
deliveries. In addition, the field interviewers directly observed the newborn’s abdomen
and cord area, wherever possible, and were to consult with medical records when they
were available. The interviewers used a structured questionnaire to gather data on
newborn status (alive/dead, visible signs of cord infection such as redness and pus, and
signs of more generalized or severe infection such as fever, poor feeding, and lethargy)
during the neonatal period; other newborn or maternal infection; behavior of the birth
attendant during delivery with regard to hand washing and wrapping the baby; initiation
of breastfeeding within an hour of birth; and intention to use a delivery kit in the future
(questionnaire available upon request). The field interviewers noted the infant’s sex and
asked questions to determine whether the infant appeared to be of low birthweight or
significantly premature at the time of birth, since these three factors might be related to
newborn susceptibility to neonatal problems or mortality. In addition, kit users were
Nepal Delivery Kit Evaluation May 2000 6