IMPORTANCE: Mothers and children living in adverse contexts are at risk of premature death. OBJECTIVE: To determine the effect of prenatal and infant/toddler nurse home visiting on maternal and child mortality during a 2-decade period (1990-2011). DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was designed originally to assess the home visiting program's effect on pregnancy outcomes and maternal and child health through child age 2 years. The study was conducted in a public system of obstetric and pediatric care in Memphis, Tennessee. Participants included primarily African American women and their first live-born children living in highly disadvantaged urban neighborhoods, who were assigned to 1 of 4 treatment groups: treatment 1 (transportation for prenatal care [n = 166]), treatment 2 (transportation plus developmental screeningfor infants and toddlers [n = 514]), treatment 3 (transportation plus prenatal/postpartum home visiting [n = 230]), and treatment 4 (transportation, screening, and prenatal, postpartum, and infant/toddler home visiting [n = 228]). Treatments 1 and 3 were included originally to increase statistical power for testing pregnancy outcomes. For determining mortality, background information was available for all 1138 mothers assigned to all 4 treatments and all but 2 live-born children in treatments 2 and 4 (n = 704). Inclusion of children in treatments 1 and 3 was not possible because background information was missing on too many children. INTERVENTIONS: Nurses sought to improve the outcomes of pregnancy, children's health and development, and mothers' health and life-course with home visits beginning during pregnancy and continuing through child age 2 years. MAIN OUTCOMES AND MEASURES: All-cause mortality in mothers and preventable-cause mortality in children (sudden infant death syndrome, unintentional injury, and homicide) derived from the National Death Index. RESULTS: The mean (SE) 21-year maternal all-cause mortality rate was 3.7% (0.74%) in the combined control group (treatments 1 and 2), 0.4% (0.43%) in treatment 3, and 2.2% (0.97%) in treatment 4. The survival contrast of treatments 1 and 2 combined with treatment 3 was significant (P = .007); the contrast of treatments 1 and 2 combined with treatment 4 was not significant (P = .19), and the contrast of treatments 1 and 2 combined with treatments 3 and 4 combined was significant (post hoc P = .008). At child age 20 years, the preventable-cause child mortality rate was 1.6% (0.57%) in treatment 2 and 0.0% (SE not calculable) in treatment 4; the survival contrast was significant (P = .04). CONCLUSIONS AND RELEVANCE: Prenatal and infant/toddler home visitation by nurses is a promising means of reducing all-cause mortality among mothers and preventable-cause mortality in their first-born children living in highly disadvantaged settings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00708695.
RCT Entities:
IMPORTANCE: Mothers and children living in adverse contexts are at risk of premature death. OBJECTIVE: To determine the effect of prenatal and infant/toddler nurse home visiting on maternal and child mortality during a 2-decade period (1990-2011). DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was designed originally to assess the home visiting program's effect on pregnancy outcomes and maternal and child health through child age 2 years. The study was conducted in a public system of obstetric and pediatric care in Memphis, Tennessee. Participants included primarily African American women and their first live-born children living in highly disadvantaged urban neighborhoods, who were assigned to 1 of 4 treatment groups: treatment 1 (transportation for prenatal care [n = 166]), treatment 2 (transportation plus developmental screening for infants and toddlers [n = 514]), treatment 3 (transportation plus prenatal/postpartum home visiting [n = 230]), and treatment 4 (transportation, screening, and prenatal, postpartum, and infant/toddler home visiting [n = 228]). Treatments 1 and 3 were included originally to increase statistical power for testing pregnancy outcomes. For determining mortality, background information was available for all 1138 mothers assigned to all 4 treatments and all but 2 live-born children in treatments 2 and 4 (n = 704). Inclusion of children in treatments 1 and 3 was not possible because background information was missing on too many children. INTERVENTIONS: Nurses sought to improve the outcomes of pregnancy, children's health and development, and mothers' health and life-course with home visits beginning during pregnancy and continuing through child age 2 years. MAIN OUTCOMES AND MEASURES: All-cause mortality in mothers and preventable-cause mortality in children (sudden infant death syndrome, unintentional injury, and homicide) derived from the National Death Index. RESULTS: The mean (SE) 21-year maternal all-cause mortality rate was 3.7% (0.74%) in the combined control group (treatments 1 and 2), 0.4% (0.43%) in treatment 3, and 2.2% (0.97%) in treatment 4. The survival contrast of treatments 1 and 2 combined with treatment 3 was significant (P = .007); the contrast of treatments 1 and 2 combined with treatment 4 was not significant (P = .19), and the contrast of treatments 1 and 2 combined with treatments 3 and 4 combined was significant (post hoc P = .008). At child age 20 years, the preventable-cause child mortality rate was 1.6% (0.57%) in treatment 2 and 0.0% (SE not calculable) in treatment 4; the survival contrast was significant (P = .04). CONCLUSIONS AND RELEVANCE: Prenatal and infant/toddler home visitation by nurses is a promising means of reducing all-cause mortality among mothers and preventable-cause mortality in their first-born children living in highly disadvantaged settings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00708695.
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