The effect of systematic pediatric care on neonatal mortality and hospitalizations of infants born with oral clefts

<p>Abstract</p> <p>Background</p> <p>Cleft lip and/or palate (CL/P) increase mortality and morbidity risks for affected infants especially in less developed countries. This study aimed at assessing the effects of systematic pediatric care on neonatal mortality and hospitalizations of infants with cleft lip and/or palate (CL/P) in South America.</p> <p>Methods</p> <p>The intervention group included live-born infants with isolated or associated CL/P in 47 hospitals between 2003 and 2005. The control group included live-born infants with CL/P between 2001 and 2002 in the same hospitals. The intervention group received systematic pediatric care between the 7^thand 28^thday of life. The primary outcomes were mortality between the 7^thand 28^thday of life and hospitalization days in this period among survivors adjusted for relevant baseline covariates.</p> <p>Results</p> <p>There were no significant mortality differences between the intervention and control groups. However, surviving infants with associated CL/P in the intervention group had fewer hospitalization days by about six days compared to the associated control group.</p> <p>Conclusions</p> <p>Early systematic pediatric care may significantly reduce neonatal hospitalizations of infants with CL/P and additional birth defects in South America. Given the large healthcare and financial burden of CL/P on affected families and the relatively low cost of systematic pediatric care, improving access to such care may be a cost-effective public policy intervention.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00097149">NCT00097149</a></p

Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]

BACKGROUND: The contribution of birth defects, including cleft lip and palate, to neonatal and infant mortality and morbidity is substantial. As other mortality and morbidity causes including infections, hygiene, prematurity, and nutrition are eradicated in less developed countries, the burden of birth defects will increase proportionally. METHODS/DESIGN: We are using cleft lip and palate as a sentinel birth defect to evaluate its burden on neonatal and infant health and to assess the effectiveness of systematic pediatric care during the first month and first two years of life in decreasing this burden. The neonatal intervention, consisting of weekly pediatric evaluation and referral to appropriate care, is delivered to about 696 infants born with cleft lip and/or palate in 47 hospitals in South America. Neonatal mortality in this group will be compared to that in a retrospective control group of about 464 infants born with cleft lip and/or palate in the same hospitals. The subgroup of infants with isolated clefts of both the lip and palate (about 264) is also randomized into two groups, intervened and non-intervened, and further followed up over 2 years. Intervened cases are evaluated by pediatricians every three months and referred for appropriate care. The intervened and non-intervened cases will be compared over study outcomes to evaluate the intervention effectiveness. Non-intervened cases are matched and compared to healthy controls to assess the burden of cleft lip and palate. Outcomes include child's neurological and physical development and family social and economic conditions. DISCUSSION: Large-scale clinical trials to improve infant health in developing countries are commonly suggested, making it important to share the methods used in ongoing studies with other investigators implementing similar research. We describe here the content of our ongoing pediatric care study in South America. We hope that this may help researchers targeting this area to plan their studies more effectively and encourage the development of similar research efforts to target other birth defects or infant outcomes such as prematurity and low birth weight

Effect of survey instrument on participation in a follow-up study: a randomization study of a mailed questionnaire versus a computer-assisted telephone interview

<p>Abstract</p> <p>Background</p> <p>Many epidemiological and public health surveys report increasing difficulty obtaining high participation rates. We conducted a pilot follow-up study to determine whether a mailed or telephone survey would better facilitate data collection in a subset of respondents to an earlier telephone survey conducted as part of the National Birth Defects Prevention Study.</p> <p>Methods</p> <p>We randomly assigned 392 eligible mothers to receive a self-administered, mailed questionnaire (MQ) or a computer-assisted telephone interview (CATI) using similar recruitment protocols. If mothers gave permission to contact the fathers, fathers were recruited to complete the same instrument (MQ or CATI) as mothers.</p> <p>Results</p> <p>Mothers contacted for the MQ, within all demographic strata examined, were more likely to participate than those contacted for the CATI (86.6% vs. 70.6%). The median response time for mothers completing the MQ was 17 days, compared to 29 days for mothers completing the CATI. Mothers completing the MQ also required fewer reminder calls or letters to finish participation versus those assigned to the CATI (median 3 versus 6), though they were less likely to give permission to contact the father (75.0% vs. 85.8%). Fathers contacted for the MQ, however, had higher participation compared to fathers contacted for the CATI (85.2% vs. 54.5%). Fathers recruited to the MQ also had a shorter response time (median 17 days) and required fewer reminder calls and letters (median 3 reminders) than those completing the CATI (medians 28 days and 6 reminders).</p> <p>Conclusions</p> <p>We concluded that offering a MQ substantially improved participation rates and reduced recruitment effort compared to a CATI in this study. While a CATI has the advantage of being able to clarify answers to complex questions or eligibility requirements, our experience suggests that a MQ might be a good survey option for some studies.</p