This study had two components. First, we developed the MDT software and design as an iterative process with the investigators and software developer and then piloting the device in the field team. After the development of the device was completed, we next trained the birth attendants and then conducted a field study in several hospitals which were participating in the HBB trial.

Development of MDT

A software program was developed to collect and record the data on an Android device. The Android operating system was selected because it is used on a wide range of cell phones and tablets, including phones in the lower end of the cost range. Selection of the Android-based system was important since the project was targeted for use in low-income country settings and thus availability of software which functioned on low-cost hardware was preferred for sustainability. After the software was programmed, it was tested for reliability and usability by RTI staff and further refined before it was deployed and field tested in Belgaum prior to initiation of the validation study.

This software was enabled with an audible mark and a physical mark entry-type system. The physical marks included easy-to-read symbols to indicate, crowning, birth, cry, or BMV. This application was published in Google Play, is available on the Google Play website under the term “Helping Babies Breathe” and may be installed through Google Play at no cost [11].

Development and beta testing of the application was started in October 2012; a stable, ready-to-use version was available in March 2013.

MDT

To operate the MDT, when a delivery was imminent, the application was turned ‘ON’ (Fig. 1) to begin recording and remained on for the duration of the delivery. Four key points were verbally marked in the recording during the delivery process by the birth attendant who called out: START (when the baby’s head crowned); BIRTH (when the baby was born), and CRY, (if the baby spontaneously cried or took a breath) or BAG (if baby did not breathe spontaneously) and the birth attendant used BMV to resuscitate the infant. After the birth activities were completed, the MDT was stopped as illustrated in Fig. 2 and the BA completed data collection by filling in the identification numbers for the birth attendant and participant on the mobile phone (Fig. 3). At a later time, the Facility Coordinator reviewed the recoding and placed the physical mark entry onto the recording.

Fig. 1 Starting the recording; User Selects “New Record” to start the process and then clicks “Record” Full size image

Fig. 2 Stopping the recording; When the session is complete, user clicks “Stop” and the system asks for confirmation to end recording Full size image

Fig. 3 Entering birth outcome information; BA is prompted to enter birth outcomes on the mobile device Full size image

The device was piloted in the month of April 2013 using a convenience sample of birth attendants who had been trained in HBB.

Field study

Setting

This study was conducted at five of the 32 Belgaum, India health facilities where BAs had been trained in HBB. Three county hospitals, one private hospital and one community health center (CHC) were selected to ensure a sample of at least 100 births per month within the study catchment area. County hospitals had 200–350 births per month, and each of the private hospitals and CHC had 200 and 100 births per month, respectively. Five nurses, one from each facility, were selected as Facility Coordinators to supervise activities at each of these facilities.

Training

Birth attendants at these facilities received a three-hour basic training in the use of the MDT device, including the accurate timing of the four key events: Crowning, Birth, Spontaneous Crying/Respiration or BMV. The BA then entered the participant identification number and basic delivery outcome information on the mobile phone. During the delivery, the BA spoke the phrases “Start (when the baby crowned),” “Birth” “Cry” and “Bag” to indicate when these events occurred, which were recorded on the MDT. After delivery, the BA reviewed the recorded information with the Facility Coordinators to ensure that the time was correctly marked on the MDT, as described below. Short paper forms were available to record the information in the event that the timer device was inadvertently not started and the reasons why the MDT was not used.

The BAs also received weekly supervised visits and onsite refresher training to review the enrollment status and use of the devices. The Facility Coordinators were instructed to observe a sample of deliveries (10 %) for which the timer was used. These Facility Coordinators were trained to independently observe births in order to collect the time interval data using a stop watch, i.e., Birth to either cry/spontaneous respiration or initiation of BMV (observer data), independent of MDT data. Facility coordinators were also trained in the process for transferring MDT data to the server.

Data collection

Data were collected both on the MDT and hard copy. Android cell phones with the MDT and charging units were placed in the delivery rooms of the participating facilities for the BAs to use. A second MDT device was available in each delivery room to record deliveries as a back-up.

The data collected on the MDT device were reviewed by the Facility Coordinator with the BAs (Fig. 4) to ensure that the corresponding markings (i.e., time of crowning, birth, cry or BMV) were completed correctly (Fig. 5). Reviewed records were then uploaded into the Google’s AppEngine service at http://helpingbabybreath.appspot.com on weekly basis. Finally, observers’ log of the events, which were collected for a sub-sample of the deliveries, were collected on paper forms and entered into a separate (Microsoft Access) database by site data entry staff. In addition, paper data collection forms were available for BAs to record the reason for not starting the device if the MDT was not activated.

Fig. 4 Post-delivery record review; When “Review” is selected, the system shows the records stored in the phone. Blue indicates not reviewed; Green indicates reviewed with an indication of the number of marks entered. The user then selects a session for review and while the recording is being reviewed, is presented with a progress bar, similar to what is seen for an audio recording, and four buttons that allows for placing a timestamp on the recording for the audible cues of “Start/Crown”, “Birth”, “Cry” or “Bag/Resuscitation” as illustrated in Fig. 5 Full size image

Fig. 5 Illustration of progress bar and timestamp mark symbols Full size image

At the completion of the MDT data collection, a brief survey of the BA’s was conducted in order to assess the MDT’s usefulness to the BAs and improve future design of the device. The survey addressed aspects of training, ease of use of the MDT, capturing data on Android platform and the use of feedback for improving future resuscitation.

Data management and statistical analysis

Data entry and transmission to the data coordinating center was completed on a weekly basis by trained data entry staff. Edits were performed centrally and resolved at the site to ensure internal consistency of data.

The research team reviewed and corrected data edits centrally on monthly basis. The data were analyzed using SAS version 9.3 (Cary, NC) to provide descriptive statistics and correlation coefficients to compare the data collected using the MDT with the data collected by the independent observers. A Bland-Altman plot was constructed to compare the correlation between Birth and Cry and Spearman correlations to compare time between Birth and BMV.

Descriptive statistics were used to present the results from the convenience sample of BAs that participated in a survey about their experiences using the MDT.

The study was approved by the ethics committees under the JNMC Institutional Ethics Committee on Human Subjects Research (IORG#0001102) and under the RTI International Institutional Review Board amendment (ID # 12940).