MOMS 2 is a follow-up study of the children from the Management of Myelomeningocele Study (MOMS). MOMS is a multi-center randomized trial of prenatal versus postnatal surgery for repair of myelomeningocele funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Eligible and consenting women carrying a singleton fetus with a myelomeningocele lesion starting at T1-S1 with evidence of hindbrain herniation, and gestational age 19-24 weeks are randomized to fetal repair in utero via hysterotomy versus standard postnatal repair for their infant shortly after birth. The children are followed until 30 months of age. However, at that age many of the implications of the disability are not yet apparent. The purpose of MOMS 2 is to determine whether prenatal repair of myelomeningocele affects adaptive behavior, cognitive functioning, motor level and function, brain morphology and microstructure, urologic health, and other aspects of health of the child at school age. In addition, the impact of prenatal surgery on the reproductive health of the mother, and on family wellbeing will be assessed. Approximately 180 of the families with children of 5 to 8 years old that participated in MOMS will be eligible for enrollment in MOMS 2. The primary outcome will be measured by the Vineland Adaptive Behavior Scales II. Cognitive function will be measured by a battery of neuropsychological tests. Motor level and function will be assessed by physical examination. Using high resolution volumetric MRI, volumetric analysis of whole and regional brain structures will be compared between the prenatal and postnatal repair groups. Diffusion tensor imaging (DTI) will be performed to determine if there are differences by group in the microstructural organization of white matter tracts, such as the corpus callosum and projection and association pathways. Magnetoencephalography (MEG) will be performed to localize areas of cortical activation and to perform functional mapping (including motor, somatosensory, visual and auditory) which can then be co-registered with the MRI and DTI data. All children will undergo video urodynamics, renal/bladder ultrasound and urine culture to evaluate urologic status. Quality of life, family impact, parenting stress and maternal reproductive functioning also will be assessed. If this intervention is shown to mitigate the negative consequences associated with spina bifida, it could improve the lives of many children and adults in the future, allowing them to live more independently and productively. Conversely, if there is little or no lasting benefit, the study results will prevent women from undergoing an invasive and expensive procedure. Regardless of the efficacy of prenatal surgery, this study will give insight into clinical and developmental course of children from before birth to school age, which can lead to a deeper understanding of the different facets of spina bifida, improved clinical care for affected children and better informed prenatal counseling for women carrying a fetus with myelomeningocele.

Public Health Relevance

The MOMS trial is designed to investigate whether performing prenatal surgery to repair the spinal defect in a fetus diagnosed with spina bifida while still in the womb is better than the usual postnatal surgery when a baby is a few days old. This study is a follow-up of the MOMS children at school age to determine whether children who received the surgery before birth have better health and mental outcomes and live more independently and function more safely and appropriately in daily life than those who received the surgery after birth. If prenatal surgery is shown to be better and the effects to last into childhood and potentially adulthood, this will provide evidence for offering this intervention to pregnant women in the future, however if there is little or no lasting benefit, it will prevent women from undergoing an invasive and expensive procedure.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HD068541-03
Application #
8527813
Study Section
Neurological, Aging and Musculoskeletal Epidemiology (NAME)
Program Officer
Willinger, Marian
Project Start
2011-08-01
Project End
2016-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2013
Total Cost
$1,294,168
Indirect Cost
$48,533
Name
George Washington University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
043990498
City
Washington
State
DC
Country
United States
Zip Code
20052
Crawley, Jennifer T; Hasan, Khader; Hannay, H Julia et al. (2014) Structure, integrity, and function of the hypoplastic corpus callosum in spina bifida myelomeningocele. Brain Connect 4:608-18
Fletcher, Jack M (2014) Alternative approaches to outcomes assessment: beyond psychometric tests. Pediatr Blood Cancer 61:1734-8
Ferschl, Marla; Ball, Robert; Lee, Hanmin et al. (2013) Anesthesia for in utero repair of myelomeningocele. Anesthesiology 118:1211-23