Early Identification of Preterm Neonates at Birth With a Tablet App for the Simplified Gestational Age Score (T-SGAS) When Ultrasound Gestational Age Dating Is Unavailable: Protocol for a Validation Study

Abstract

BackgroundAlthough rates of preterm birth continue to increase globally, identification of preterm from low birth weight infants remains a challenge. The burden of low birth weight vs preterm is greatest in resource-limited settings, where gestational age (GA) prior to delivery is frequently not known because ultrasound in early pregnancy is not available and estimates of the date of the mother’s last menstrual period (LMP) may not be reliable. An alternative option is to assess GA at birth to optimize referral and care of preterm newborns. We previously developed and pilot-tested a system to measure the simplified gestational age score (SGAS) based on 4 easily observable neonatal characteristics.ObjectiveThe objective of this study is to adapt the scoring system as a tablet app (potentially scalable approach) to assess feasibility of use and to validate whether the scoring system accurately predicts prematurity by itself, over and above birth weight in a large sample of newborns.MethodsThe study is based in Nagpur, India, at the Research Unit of the National Institute of Child Health and Human Development’s Global Network for Women’s and Children’s Health Research. The Android tablet app for the SGAS (T-SGAS) displays de-identified photographs of skin, breasts, and genitalia across a range of GAs and line drawings of infant posture. Each item is associated with a score. The user is trained to choose the photograph or line drawing that most closely matches the newborn being evaluated, and the app determines the neonate’s GA category (preterm or term) from the cumulative score. The validation study will be conducted in 3 second level care facilities (most deliveries in India occur in hospitals, and women known to be at risk of preterm birth are referred to second level care facilities). Within 24 hours of delivery, women and their babies who are stable will be enrolled in the study. Two auxiliary nurse midwives (ANMs) blinded to prior GA assessments will use the T-SGAS to estimate the GA status of the newborn. An independent data collector will abstract the GA from the ultrasound recorded in the hospital chart and record the date of the mother’s LMP. Eligibility for analysis is determined by the ultrasound and LMP data being collected within 1 week of each other to have a rigorous assessment of true GA.ResultsPublication of the results of the study is anticipated in 2019.ConclusionsUntil GA dating by ultrasound is universally available and easy to use in resource-limited settings, and where there are restrictions on ultrasound use due to their use for sex determination and abortion of female fetuses, this study will determine whether the T-SGAS app can accurately assess GA in risk categories at birth.Trial RegistrationClinicalTrials.gov NCT02408783; https://clinicaltrials.gov/ct2/show/NCT02408783 (Archived by Webcite at http://www.webcitation.org/75S2kmr3T)International Registered Report Identifier (IRRID)DERR1-10.2196/11913

Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review

“…This may facilitate their inclusion in clinical trial protocols and guidelines. However, data collection may need to be adapted to the healthcare setting 25. For example, information on fetal loss might be difficult to collect in settings with limited resources.…”

Early identification of preterm neonates at birth with a Tablet App for the Simplified Gestational Age Score (T-SGAS) when ultrasound gestational age dating is unavailable: A validation study

“…This was a cross-sectional validation study to evaluate the accuracy of T-SGAS to ascertain postnatal GA within 24 hours of birth. Details of the methods used have been described elsewhere [8]. Briefly, the study was conducted at three second-level care birthing facilities in and around Nagpur in central India.…”

“…This was done to avoid any possibility of the ANM's knowing the GA of the neonate. Data collection and transmission was on real-time basis to a central data server [8].…”

“…T-SGAS was developed by using the most predictive items from the 12-item New Ballard Score (NBS), 22-item Dubowitz score (DWS) and 11-item Meharban Singh (MS) and validated against the Best obstetrics Estimate (BOE) in low birth weight (LBW) newborns in India [9]. Because it showed promising results for estimation of GA in LBW newborn and was easy to by nursing staff in the community it was adapted to a pictorial tablet app (T-SGAS) [8].…”

“…Considering these implementation gaps, we developed a tablet-based pictorial GA assessment tool, the "Tablet based-Simplified Gestational Age Score" or T-SGAS. T-SGAS was adapted from a previously developed and tested simplified gestational age scoring system [8,9]. The aim of this study was to assess the accuracy of T-SGAS in assessing prematurity of newborn, over and above birthweight.…”