Household Air Pollution and Health: A Multi-country LPG Intervention Trial

Birth weight

时间窗: Within 24 hours of birth (up to 5 months post-randomization of mother)

Birth weight is assessed by a trained nurse or health worker within 24 hours of birth. Infants are weighed naked or in a pre-weighed blanket. Weight is measured to the nearest 10 g using a digital electronic scale, if performed by the study field staff; otherwise, hospital medical records are used.

Change in Systolic Blood Pressure

时间窗: Baseline, 3, 5, 9, 12, and 18 months post-randomization (24, 36, 48, and 60 months of age)

Systolic blood pressure will be assessed in the older adult women in the intervention and control arms using automatic sphygmomanometers (Omron HEM-907XL; Osaka, Japan). The study team will use the procedures adapted from previously validated methods and cardiovascular outcome studies, following recommendations for the American Heart Association and the European Society of Hypertension.

Change in Child Linear Growth

时间窗: Birth (3-5 months post-randomization), and 3, 6, 9, 12, 24, 36, 48 and 60 months of age

Linear growth of children will be assessed in centimeters of height from the time of birth until 60 months of age.

Change in Caregiver Reported Early Childhood Development Instrument (CREDI) Score

时间窗: 3 months of age to 24 months of age

Child development will be assessed with the Caregiver Reported Early Childhood Development Instrument (CREDI). The CREDI is a population-level measure of early childhood development (ECD) for children from 0-2 years of age. The CREDI assesses 5 domains of child development: 1) motor development (fine and gross motor), 2) language development (expressive and receptive language), 3) cognitive development (executive function, problem solving and reasoning, and pre-academic knowledge), 4) socio-emotional development (emotional and behavioral self-regulation, emotional knowledge, and social competence), and 5) mental health (internalizing and externalizing behaviors). The CREDI long form has 117 items and the number of questions answered depends on the age of the child. Responses of "yes" are coded as 1 and "no" is coded as 0; certain items are reverse coded. Total raw scores increase by age (with developmental progression), and higher scores indicate increased development.

Change in Malawi Developmental Assessment Tool (MDAT) Score

时间窗: 36, 48 and 60 months of age

The MDAT measures gross motor (39 items), fine motor (42 items), language/cognition (40 items) and social skills (36 items). Originally developed and validated in rural Malawi, it has now been used in over 25 countries with more than 8,000 children as both a clinical and research tool. The MDAT is a continuous test with start and stop rules. Most items are administered directly to the child and items that are not easily observed (e.g., child speaks in full sentences; child understands sharing with others; child can dress self) are administered by parent report. Children receive either a pass or fail for each item, and summed pass scores can produce a composite score as well as domain-specific scores. Total scores range from 0 to 157 where higher scores indicate greater neurodevelopment.

Incidence of HAPIN Defined Severe Pneumonia

时间窗: Up to 12 months after birth

The number of times a child has severe pneumonia over their period of follow-up during the first year of life is assessed. For this study pneumonia criteria are adapted from the WHO classification of childhood pneumonia (2014) and there are 3 algorithms for case criteria: 1) the presence of cough and/or difficult breathing and at least 1 general danger sign plus evidence of pneumonia on lung imaging (i.e., lung ultrasound or chest x-ray), or 2) the presence of cough and/or difficult breathing and hypoxemia (measured either via pulse oximetry (SpO2), or observing a child requiring advanced respiratory support (i.e., intubation and mechanical ventilation, non-invasive ventilation with continuous or bi-level positive airway pressure support, or high-flow nasal cannula oxygen), or 3) children who die prior to evaluation but their death is attributed to pneumonia by verbal autopsy. Cases of pneumonia are recorded children present to HAPIN health facilities with respiratory symptoms.

Length-for-age z-score 2 standard deviations below the standard

时间窗: 12 months after birth

The primary outcome measured is stunting at one year of age, defined as a length-for-age z-score (LAZ) that is 2 standard deviations below the median of the growth standard. Infant length is assessed at birth and quarterly thereafter, until the child is 12 months old. Z-scores are calculated using the 2006 World Health Organization (WHO) Multi-Growth Reference Standard (MGRS).