RFA-R14-001: EHDI C-Section

DRDC Solicitation #:  RFA-R14-001

Project Title: Birth by Cesarean Delivery and Failure on First Otoacoustic Emissions Hearing

Maximum Budget: $60,000 (includes direct and indirect costs of applicant)
NOTE: All budget amounts are subject to the availability of funding.
Project period:  1 year
Anticipated Number of Awards:  Up to 2
Project start date:  September 30, 2014

Eligible Applicants:

Proposals are invited from researchers and health professionals that have or can gain access to EHDI data currently collected and/or maintained by the State’s Department of Health or other designated State agency.

Description:

Healthy People 2020 Focus Area(s) aligned with this project:
ENT-VSL-1: Increase the proportion of newborns who are screened for hearing loss by no later than age 1 month, have audiologic evaluation by age 3 months, and are enrolled in appropriate intervention services no later than age 6 months

Center/Division goal(s) and priorities aligned with this research project: Division of Human Development and Disability (DHDD): Ensure that all newborns are screened and assessed for hearing loss and receive appropriate intervention according to established guidelines.

Purpose: The purpose of this study is to determine if babies born by cesarean delivery are more likely to fail the first otoacoustic emissions hearing test.

Background: Currently 98 percent of infants born in the United States are screened for hearing loss shortly after birth and approximately 2 percent of those babies are referred for additional testing. A small percentage of those referred are diagnosed with hearing loss for a prevalence of 1 to 3 cases per 1,000 screened.  According to the National Early Hearing Detection and Intervention (EHDI) goals, a referral rate of 4 percent or less is recommended because, without missing any infants, it is best to minimize the number of repeat screens to minimize cost and the potential psychological impact associated with a failed hearing screen.

Universal newborn hearing screening can produce a large number of false-positive test results. The percentage of false positives ranges from more than 30 percent for one-step programs, such as testing the newborn only once before hospital discharge using Otoacustic Emissions (OAE) test, to less than 1 percent with a two-step process, such as retesting a child before discharge if the initial test is positive. Recent research has indicated that infants delivered by Cesarean section (C-section) had significantly higher failure rates on the first OAE hearing test. As a result, it has been recommended that the first OAE test after C-section should preferably be delayed beyond 48 hours of age to improve OAE passage and minimize maternal anxiety and cost. Additional research is needed in order to decide if this is an appropriate policy that should be implemented by all Newborn Hearing Screening programs.

Research Goals and Objectives: The CDC/EHDI Team is interested in research that will collect and analyze hearing screening data to determine if the mode of delivery (vaginal delivery vs. C-section), time of screening and other pertinent variables influence the sensitivity and specificity of newborn hearing screening programs. Data collected must include at a minimum initial screening status, testing methodology (OAE vs. ABR), time of screening, mode of delivery, birth weight, gestational age, Apgar score, risk factors for hearing loss (e.g. birth defects, ototoxic medications, etc.) and hearing status (e.g. normal hearing vs. hearing loss)

Special Instructions for applicants:

Although a wide range of proposals may be considered, it is important that the applicant clearly outline the objectives and design of the study. The applicant should clearly describe all aspects of the proposed study, including the methodology chosen and analyses that will be used.

Successful applications must include the following:

  1. Description of the research, including sample size and statistical power
  2. Detailed analytic plan, including variables to be analyzed and timeline of activities
  3. Methods to be used to define and identify the study population (Electronic Health Records, Paper records, etc.), as well as data collection plan and instruments
  4. Detailed budget, including identification of any sub-contractors
  5. Protection of human subjects

Further, successful applicants will likely:

  1. Demonstrate knowledge of and experience with the proposed research methodology
  2. Have prior experience in working with state EHDI programs
  3. Have prior experience in conducting the specific research methodology proposed
  4. Demonstrate experience in the dissemination of research findings

Describe the potential public health impact of this opportunity:

Currently the recommendation is to screen babies for hearing loss before hospital discharge. To comply with this recommendation, many infants are being screened within the first few hours after birth, when, according to previous reports, the chances for infants delivered via C-section to fail the test are higher. This research will help to determine if new rules should be created to delay the time of screening for those infants and therefore decrease the percentage of false positives. In turn this should help lower program costs and decrease anxiety and stress of the parents.

References:

1. Smolkin T, Mick O, Dabbah M, Blazer S, Grakovsky G, Gabay N, Gordin A, Makhoul IR. Birth by cesarean delivery and failure on first otoacoustic emissions hearing. Pediatrics. 2012 Jul;130(1):e95-100

2. Smolkin T, Awawdeh S, Blazer S, Mick O, Makhoul IR. Delayed first otoacoustic emission test decreases failure on neonatal hearing screening after caesarean delivery. Acta Paediatrica, 2013, 102, pp e194-e199

3. American Academy of Pediatrics, Joint Committee on Infant Hearing. Year 2007 position statement: principles and guidelines for early hearing detection and intervention programs. Pediatrics. 2007;120(4):898–921.

4. Gaffney M, Eichwald J, Grosse SD, Mason CA.  Identifying infants with hearing loss – United States, 1999-2007. MMWR Morb Mortal Wkly Rep. 2010 Mar 5;59(8):220-3.

5. Gaffney M, Green DR, Gaffney C.  Newborn hearing screening and follow-up: are children receiving recommended services?  Public Health Rep. 2010 Mar-Apr; 125(2):199-207.

6. Clarke P, Iqbal M, Mitchell S. A comparison of transient-evoked otoacoustic emissions and automated auditory brainstem responses for pre-discharge neonatal hearing screening. Int J Audiol. 2003;42:443–7.

7. Clemens CJ, Davis SA, Bailey AR. The false-positive in universal newborn hearing screening. Pediatrics. 2000;106:e7.

8. Stuart A, Moretz M, Yang EY. An investigation of maternal stress after neonatal hearing screening. Am J Audiol. 2000;9:135–41.

9. Russ SA, Kuo AA, Poulakis Z, Barker M, Rickards F, Saunders K, et al. Qualitative analysis of parents’ experience with early detection of hearing loss. Arch Dis Child. 2004;89:353–358