Impact Of Sunflower Oil Massage On Neonatal Mortality In Nepal
Luke C Mullany
International Healthjohns Hopkins University
Grant 1R01HD060712-01 from Eunice Kennedy Shriver National Institute Of Child Health & Human Development IRG: NSCF
Abstract: Four million neonatal deaths occur annually and account for 40 percent of under-five mortality. These deaths occur predominately in low-resource settings where the majority of infants are born at home. In settings of high neonatal mortality risk, up to 50 percent of deaths are attributable to infection. The long-term objective of our research program is to identify simple, affordable, and effective interventions that can be delivered at the community level in low-resource settings to reduce neonatal and early infant mortality. There is increasing evidence of the role of the neonatal skin and the potential for newborn massage with topical emollients in providing protection from invasive pathogens. This research project focuses on evaluating the impact of newborn massage with sunflower seed oil on neonatal mortality and infections, relative to massage with mustard oil, which is provided almost universally to tens of millions of newborns in South Asia each year. The primary specific aim (Aim 1) is to compare the neonatal mortality risk among infants randomized to receive repeated full-body massage during the neonatal period with either sunflower seed oil or mustard seed oil. Secondary aims include a between-group comparison of mortality risk among preterm infants (Aim 2) and a comparison of the incidence of probable severe disease (sepsis) between the sunflower and mustard oil groups (Aim 3). The study population will be all live-born infants delivered within our community-based research site in Sarlahi District of southern Nepal. This site is divided into 430 communities that will be randomized to either sunflower or mustard oil. Pregnant women within the catchment area will be recruited mid-pregnancy, and provided with a set of common basic antenatal interventions (tetanus toxoid, clean delivery kit, iron-folate supplements, and basic educational messages). Women will also be provided with either sunflower seed oil or mustard oil, depending on the random allocation of their cluster of residence. The oil, sufficient in quantity to provide full-body massage three times daily for 28 days, will be provided by locally resident, village-level workers along with guidelines on the use of the oil and actual conduct of the massage. All women will be followed to pregnancy outcome. After birth of the infant, the local project workers will visit each day for the first week of life to continue promoting the massage and measuring compliance. A team of data collectors will visit all infants at home on days 1, 3, 7, 10, 14, and 28 to record vital status and basic signs of morbidity. The primary outcome is mortality within 28 days of birth. For the secondary morbidity outcome, a clinical sign- based algorithm for defining probable sepsis will be utilized. To detect a 20 percent reduction in all-cause neonatal mortality with 90 percent power and Type I error of 5 percent, the required sample size per group is 13,601. This sample size accounts for the clustered design and 5 percent loss to follow up. Given the population and crude birth rate in the study setting, recruitment of the required sample is expected to take 3.4 years. Millions of newborn infants in poor rural communities of South Asia receive the traditional care practice of repeated full-body massage with mustard oil during the first few weeks of life. While massage of the baby has some benefits, the choice of oil is very important. In fact, mustard oil may be toxic and lead to breakdown of the skin´s protective barrier and increase the risk of infection and death. Alternatively, newborn massage with sunflower seed oil has been shown to reduce the risk of infection and death among preterm infants in hospitals. A study of the relative utility of massage with sunflower seed oil in protecting newborns from infection and mortality compared to mustard oil is urgently needed. If efficacious, sunflower seed oil can be promoted as a simple, low-cost intervention that can save the lives of babies in low-resource communities where mortality rates are highest
Project start date: 2009-09-10
Project end date: 2014-06-30
Sponsored Links Excellgen http://Excellgen.com
Grants awarded to Luke C Mullany
INCIDENCE, RISK FACTORS, AND CONSEQUENCES OF NEONATAL HYPOTHERMIA IN NEPAL
Luke C Mullany, Assistant Professor
Johns Hopkins University, 3400 N Charles St, Baltimore, Md 21218
Grant 5R03HD055346-02 from Eunice Kennedy Shriver National Institute Of Child Health & Human Development
Abstract: Neonatal hypothermia is recognized as contributing to mortality and morbidity, but data are largely lacking from low-resource settings in developing countries where the majority of high-risk neonates are born. The overall goal of this secondary data analysis is to estimate the incidence, risk factors, and health consequences of hypothermia among newborns in a rural population of southern Nepal. The data sets that will be used to address these issues derive from two large community-based trials undertaken between 1998 and 2005. Together, these studies followed 27,000 newborns from birth to 28 days, recording axillary temperature up to 11 times during home visits as a covariate for the primary outcomes of neonatal mortality and infection. The aims of the proposed analyses include the following 1) Estimation of the timing and incidence of mild, moderate, and severe hypothermia through the neonatal period and examination of maternal, neonatal, and newborn care factors associated with hypothermia. Key measures of potential risk factors include birth weight, gestational age, and thermal care practices such as bathing, drying, wrapping, oil massage, and skin to skin contact. Daily ambient temperature data are available and will be correlated with axillary temperature measures to examine seasonality of hypothermia risk. 2) Quantify the subsequent risk of mortality and morbidity associated with neonatal hypothermia. Prospectively collected vital status data through 28 days will allow comparison of mortality risk between hypo- and normo- thermic infants, and assessment of the variability in risk by severity and timing of hypothermia. Verbal autopsy data are available for all neonatal deaths and risk regression models will be adjusted for a wide range of potential confounding variables. The risk of probable sepsis defined using an algorithm composed of direct and indirect signs of morbidity collected at each home-visit will also be compared with hypothermic status. 3) Assess the impact of varying the current WHO definitions for mild, moderate, and severe hypothermia on the quantified incidence, risk factors and consequences of hypothermia. The overall incidence and attributable risk estimates of associated factors will be compared across alternate definitions. These analyses will fill an important gap in our understanding of the burden and impact of hypothermia on neonatal mortality and morbidity in low-resource settings. Conclusions will inform upon the design of community-based neonatal care programs that include behavior change components that aim to reduce hypothermia and improve thermal care. Examination of alternate cutoffs for defining hypothermia severity may improve design of low-cost technologies for identification and subsequent management of hypothermic infants in the community
Keywords: 0-6 weeks old; Address; Algorithms; Analysis, Data; Armpit; Aspiration, Respiratory; Autopsy; Axilla; Axillary; Bathing; Baths; Behavioral; Birth; Birth Weight; Body Temperature; Breathing; Caring; Categories; Cause of Death; Cessation of life; Characteristics; Chest; Communication; Communities; Confounding Factor, Epidemiologic; Confounding Factors (Epidemiology); Confounding Variables; Daily; Data; Data Analyses; Data Set; Dataset; Death; Developed Countries; Developed Nations; Developing Countries; Developing Nations; Diagnosis; Disease regression; Fetal Age; Fetal Maturity, Chronologic; Gestational Age; Goals; Health; Home Visits; Home visitation; House Call; Household; Hypothermia; Incidence; Industrialized Countries; Industrialized Nations; Infant; Infant, Newborn; Infection; Inhalation; Inhaling; Inspiration, Respiratory; Less-Developed Countries; Less-Developed Nations; Life; Massage; Measures; Modeling; Morbidity; Morbidity - disease rate; Mortality; Mortality Vital Statistics; Neonatal; Neonatal Mortality; Nepal; Newborn Infant; Newborns; Oils; Outcome; Parturition; Perception; Population; Programs (PT); Programs [Publication Type]; Range; Regression; Reporting; Research Resources; Resources; Risk; Risk Estimate; Risk Factors; Role; Rural Population; Sepsis; Severities; Skin; Technology; Temperature; Third-World Countries; Third-World Nations; Thorace; Thoracic; Thorax; Time; Translating; Translatings; Umbilical Cord; Umbilical cord structure; Under-Developed Countries; Under-Developed Nations; Underarm; Vital Status; WHO; Week; World Health Organization; base; behavior change; bloodstream infection; cold temperature; cost; day; design; designing; home visit; hypothermia, natural; improved; inspiration; language translation; low temperature; massage therapy; natural hypothermia; necropsy; neonatal mortalities; neonate; newborn human (0-6 weeks); newborn mortality; postmortem; programs; response; social role
Project start date: 2007-07-01
Project end date: 2010-06-30
Budget start date: 1-JUL-2008
Budget end date: 30-JUN-2010
PFA/PA: PA-06-180
5R03HD055346-02 (2008): $0
1R03HD055346-01 (2007): $82000
IMPACT OF SUNFLOWER OIL MASSAGE ON NEONATAL MORTALITY IN NEPAL
Luke C Mullany, Associate Professor
Johns Hopkins University, W400 Wyman Park Building, Baltimore, Md 21218
Grant 5R01HD060712-02 from Eunice Kennedy Shriver National Institute Of Child Health & Human Development
Abstract: Four million neonatal deaths occur annually and account for 40 percent of under-five mortality. These deaths occur predominately in low-resource settings where the majority of infants are born at home. In settings of high neonatal mortality risk, up to 50 percent of deaths are attributable to infection. The long-term objective of our research program is to identify simple, affordable, and effective interventions that can be delivered at the community level in low-resource settings to reduce neonatal and early infant mortality. There is increasing evidence of the role of the neonatal skin and the potential for newborn massage with topical emollients in providing protection from invasive pathogens. This research project focuses on evaluating the impact of newborn massage with sunflower seed oil on neonatal mortality and infections, relative to massage with mustard oil, which is provided almost universally to tens of millions of newborns in South Asia each year. The primary specific aim (Aim 1) is to compare the neonatal mortality risk among infants randomized to receive repeated full-body massage during the neonatal period with either sunflower seed oil or mustard seed oil. Secondary aims include a between-group comparison of mortality risk among preterm infants (Aim 2) and a comparison of the incidence of probable severe disease (sepsis) between the sunflower and mustard oil groups (Aim 3). The study population will be all live-born infants delivered within our community-based research site in Sarlahi District of southern Nepal. This site is divided into 430 communities that will be randomized to either sunflower or mustard oil. Pregnant women within the catchment area will be recruited mid-pregnancy, and provided with a set of common basic antenatal interventions (tetanus toxoid, clean delivery kit, iron-folate supplements, and basic educational messages). Women will also be provided with either sunflower seed oil or mustard oil, depending on the random allocation of their cluster of residence. The oil, sufficient in quantity to provide full-body massage three times daily for 28 days, will be provided by locally resident, village-level workers along with guidelines on the use of the oil and actual conduct of the massage. All women will be followed to pregnancy outcome. After birth of the infant, the local project workers will visit each day for the first week of life to continue promoting the massage and measuring compliance. A team of data collectors will visit all infants at home on days 1, 3, 7, 10, 14, and 28 to record vital status and basic signs of morbidity. The primary outcome is mortality within 28 days of birth. For the secondary morbidity outcome, a clinical sign- based algorithm for defining probable sepsis will be utilized. To detect a 20 percent reduction in all-cause neonatal mortality with 90 percent power and Type I error of 5 percent, the required sample size per group is 13,601. This sample size accounts for the clustered design and 5 percent loss to follow up. Given the population and crude birth rate in the study setting, recruitment of the required sample is expected to take 3.4 years. Millions of newborn infants in poor rural communities of South Asia receive the traditional care practice of repeated full-body massage with mustard oil during the first few weeks of life. While massage of the baby has some benefits, the choice of oil is very important. In fact, mustard oil may be toxic and lead to breakdown of the skin´s protective barrier and increase the risk of infection and death. Alternatively, newborn massage with sunflower seed oil has been shown to reduce the risk of infection and death among preterm infants in hospitals. A study of the relative utility of massage with sunflower seed oil in protecting newborns from infection and mortality compared to mustard oil is urgently needed. If efficacious, sunflower seed oil can be promoted as a simple, low-cost intervention that can save the lives of babies in low-resource communities where mortality rates are highest
Keywords: 0-6 weeks old; 2, 4, 11, 13-Tetraazatetradecanediimidamide, N, N``-bis(4-chlorophenyl)-3, 12-diimino-; Accounting; Active Follow-up; Algorithms; Antisepsis; Area; Asia; Birth; Birth Rate; Catchment Area; Cessation of life; Chlorhexidine; Clinical; Communities; Data; Death; Diarrhea; Disease; Disorder; Dose; Drug Administration, Topical; Emollients; Exposure to; Fe element; Folate; Gestation; Goals; Guidelines; HOSP; Health; Helianthus species; Home; Home environment; Hospital Infections; Hospital acquired infection; Hospitals; Hydrogen Oxide; Incidence; Infant; Infant Mortality; Infant Mortality Total; Infant, Newborn; Infant, Premature; Infection; Intervention; Intervention Strategies; Investigators; Iron; Lead; Life; Low Birth Weight Infant; Massage; Measures; Morbidity; Morbidity - disease rate; Mortality; Mortality Vital Statistics; Mustard; Mustard (food); Neonatal; Neonatal Mortality; Nepal; Newborn Infant; Newborns; Nosocomial Infections; Oils; Outcome; Parturition; Pb element; Penetration; Plant Embryos; Play; Population; Population Study; Postneonatal Mortality; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Infant; Programs (PT); Programs [Publication Type]; R01 Mechanism; R01 Program; RPG; Random Allocation; Random Selection; Randomized; Recovery; Recruitment Activity; Relative; Relative (related person); Research; Research Grants; Research Personnel; Research Project Grants; Research Projects; Research Projects, R-Series; Research Resources; Researchers; Resources; Respiratory Infections; Respiratory Tract Infections; Risk; Role; Rural Community; Sample Size; Sampling; Seeds; Sepsis; Site; Skin; Sunflower Oil; Sunflowers; Testing; Tetanus; Tetanus Toxoid; Time; Topical application; Umbilical Cord; Umbilical cord structure; VLBW (human); Visit; Vital Status; Vitamin A; Water; Woman; Zygotes, Plant; attributable death; attributable mortality; base; bloodstream infection; clostridial tetanus; comparison group; cost; design; designing; disease/disorder; effective intervention; follow-up; heavy metal Pb; heavy metal lead; improved; improved functioning; institutional infection; interventional strategy; keratinocyte; low birth weight infant human; low birthweight; massage therapy; mustard oil; neonatal death; neonatal mortalities; newborn human (0-6 weeks); newborn mortality; pathogen; premature baby; premature infant human; preterm baby; preterm infant; preterm infant human; preterm neonate; prevent; preventing; primary outcome; programs; public health relevance; randomisation; randomization; randomized trial; randomly assigned; recruit; residence; retinol; seed; social role; sunflower seed oil; topical administration; topical drug application; topically applied; traditional care
Relevance: RELEVANCE Millions of newborn infants in poor rural communities of South Asia receive the traditional care practice of repeated full-body massage with mustard oil during the first few weeks of life. While massage of the baby has some benefits, the choice of oil is very important. In fact, mustard oil may be toxic and lead to breakdown of the skin´s protective barrier and increase the risk of infection and death. Alternatively, newborn massage with sunflower seed oil has been shown to reduce the risk of infection and death among preterm infants in hospitals. A study of the relative utility of massage with sunflower seed oil in protecting newborns from infection and mortality compared to mustard oil is urgently needed. If efficacious, sunflower seed oil can be promoted as a simple, low-cost intervention that can save the lives of babies in low-resource communities where mortality rates are highest
Project start date: 2009-09-10
Project end date: 2014-06-30
Budget start date: 1-JUL-2010
Budget end date: 30-JUN-2011
PFA/PA: PA-07-070
5R01HD060712-02 (2010): $585127
Luke C Mullany
Johns Hopkins University
Project start date: 2009-09-10
Project end date: 2014-06-30