Prospective identification of congenital cytomegalovirus infection in newborns using real-time polymerase chain reaction assays in dried blood spots.

BACKGROUND: Congenital cytomegalovirus (CMV) infection is a public health issue, and implementation of neonatal screening has been debated. Detection of CMV DNA by polymerase chain reaction (PCR) of dried blood spots (DBS) routinely collected for metabolic screening from all newborns has been proposed for congenital CMV infection screening. The goal of this study was to prospectively assess the performance of 2 CMV PCR assays of DBS for CMV neonatal screening in a selected population of neonates. METHODS: We studied prospective congenital CMV screening in a population of neonates either born with symptoms compatible with congenital CMV or born to mothers with a history of primary infection during pregnancy. For each neonate, 2 CMV PCR assays of DBS were blindly performed in parallel with a gold standard technique (ie, CMV PCR of a urine sample). RESULTS: Two hundred seventy-one neonates were studied, and CMV infection, defined by a positive urine sample in the first week of life, was confirmed in 64 (23.6%). Nineteen infected (29.7%) neonates were symptomatic, and 45 (70.3%) were asymptomatic. The ranges of sensitivity, specificity, positive predictive value, and negative predictive value for the 2 CMV PCR assays of DBS were 95.0%-100%; 98.1%-99.0%; 94.1%-96.9%, and 98.5%-100%, respectively. CONCLUSIONS: The sensitivity and specificity of both CMV PCR assays of DBS to identify congenital CMV were very high in this population of neonates with a high risk of sequelae. These new data should be considered in the ongoing debate on the appropriateness of the use of DBS as a sample to screen for congenital CMV infection.

Apgar scores reported in personal child health records: validity for epidemiological studies?

AIM: In epidemiological studies on children, information in the neonatal period that might affect children's long-term health could be extracted from the personal child health record (PCHR), because the booklet exists in most countries. We aimed to assess, in individual children, the validity of Apgar scores reported in the PCHR using maternity medical records as the gold standard. METHODS: In two French hospitals, 435 women who had a child in January 2006 were recruited and 90% filled in a postal questionnaire 6 weeks after delivery, copying neonatal information (including Apgar scores) from the PCHR. This information was compared with data independently recorded at birth by physicians in maternity medical records. RESULTS: We found that the proportion of missing Apgar scores in the PCHR was higher when scores in the medical records were lower. Moreover, Apgar scores reported in the PCHR were overestimated when scores in the medical records were low. Using medical records as the gold standard, specificity for PCHR-reported 1-min Apgar score was 100% and sensitivity 33%. Similar trends were found for the 5-min score. This supports the hypothesis that information considered as 'socially sensitive' by physicians may be intentionally altered in PCHRs. CONCLUSIONS: Apgar scores reported in PCHRs may not yield reliable information for epidemiological studies. When the PCHR is the only source of information for the neonatal period in an epidemiological study, it would be preferable to use a composite neonatal indicator rather than the Apgar score.

Perinatal factors reported by mothers: do they agree with medical records?

As perinatal events have been linked with diseases of later onset, epidemiological studies on child development and adult health require information on the perinatal period. When national neonatal registers do not exist, review of medical records may be impractical. However, neonatal information could be obtained by asking mothers to complete a postal questionnaire using data from the Personal Child Health Record (PCHR). We assessed agreement between medical records and mothers' reports for information on delivery and the newborn's condition at birth, based on the PCHR, a short time after delivery. Of 711 women giving birth in 3 French hospitals and invited to participate in the study, 580 (82%) completed a postal questionnaire 6 weeks after delivery, copying the data recorded in the PCHR when available. Information on pregnancy, delivery and the newborn's health at birth was independently extracted from medical records by physicians of the maternity departments. Agreement between medical records and maternal reports for a range of perinatal factors was assessed in 580 newborn-mother dyads using kappa coefficients. Agreement was excellent for first and second stages of delivery, gestational age, birth weight, birth size and head circumference (kappa coefficients 0.80-1.00) and good for hospitalization during pregnancy, but poor for Apgar scores. With this exception, mothers' reports appeared reliable when compared with medical records. As PCHRs exist in most developed countries, this approach could be used in epidemiological studies on child development to increase the reliability of mothers' reports of their newborn's condition at birth.