The Utility of MRI Scoring to Predict Neurodevelopmental Outcomes in Survivors of Twin-to-Twin Transfusion Syndrome

NCT02249624 | Completed

• 1 other identifier: 23854
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Twins who share a placenta but have two separate sacs of amniotic fluid (monochorionic-diamniotic) are at risk of developing twin-to-twin transfusion syndrome (TTTS). TTTS results from anastomoses in the placenta that lead to unequal sharing of blood, causing abnormal blood flow to the twins. The donor twin may have low fluid levels, poor growth, and anemia. The recipient twin can have high fluid levels, high red blood cell counts, heart failure, and hydrops. Having TTTS, especially if there is demise of one twin or if disease is severe enough to warrant laser photocoagulation of the anastomotic sites, puts the surviving fetuses at risk for brain injury due to hypoxia, ischemia, or reperfusion injuries. Magnetic Resonance Imaging (MRI) is superior to ultrasound at detecting subtle cerebral injuries. An MRI scoring scale has been developed for use in very low birth weight infants that has been shown to correlate with neurodevelopmental outcomes, but it has not been tested in this patient population. Our center's guidelines recommend fetal MRI prior to intervention, at 32 weeks gestational age, and on the infants at term corrected gestational age. Infants who were treated for TTTS in utero are seen in Nursery Follow-up Clinic at 4 months of age, 8 months of age, and for Bayley Scales evaluations at 15-18 months of age and at 2-3 years of age. The purpose of this study is to correlate brain MRI score with neurodevelopmental outcomes in survivors of TTTS that have either required fetal surgical intervention or had demise of their cotwin. The investigators predict that more severe white and gray matter injury as determined by the Woodward/Inder grading scale will be positively associated with worse neurodevelopmental outcomes.

Conditions

Fetofetal Transfusion

Keywords

Twin to twin transfusion syndrome; Developmental disabilities; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Composite outcome of neurodevelopmental impairment - final

  Defined by mental, language, or physical developmental index \< 2 standard deviations from the mean on the Bayley Scales of Infant Development III, neurosensory impairment (hearing loss requiring aids or blindness), or the diagnosis of cerebral palsy.

  3 years of age

Secondary Outcomes (4)

• Developmental delay - 4 months

  4 months of age

• Developmental delay - 8 months

  8 months of age

• Neurodevelopmental impairment - 15 months

  15 months of age

• MRI results

  Term gestational age

Study Arms (1)

Survivors of TTTS

Infants who have survived TTTS to hospital discharge, have an MRI at term, and return for nursery follow-up clinic.

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pregnancies affected by TTTS will be identified through referrals from the St. Louis Fetal Care Institute. Surviving infants of those pregnancies that required fetal laser surgery, or had death of the cotwin, will be approached for enrollment.

You may qualify if:

• Infants who suffered from TTTS in utero that either required fetal laser photocoagulation or had death of their cotwin
• Born after implementation of our TTTS protocol in September 2013
• Complete postnatal MRI and follow-up at Cardinal Glennon Children's Medical Center, or at an outside hospital and release medical information to the study

You may not qualify if:

• Infants who did not have TTTS, or not severe enough to warrant fetal intervention or demise of the cotwin
• Infants who do not complete their follow-up per protocol

Sponsors & Collaborators

• Catherine Cibulskis, MD: lead
• St. Louis University: collaborator

Study Sites (1)

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Related Publications (7)

• Simonazzi G, Segata M, Ghi T, Sandri F, Ancora G, Bernardi B, Tani G, Rizzo N, Santini D, Bonasoni P, Pilu G. Accurate neurosonographic prediction of brain injury in the surviving fetus after the death of a monochorionic cotwin. Ultrasound Obstet Gynecol. 2006 May;27(5):517-21. doi: 10.1002/uog.2701.

  PMID: 16586472 BACKGROUND

• Righini A, Kustermann A, Parazzini C, Fogliani R, Ceriani F, Triulzi F. Diffusion-weighted magnetic resonance imaging of acute hypoxic-ischemic cerebral lesions in the survivor of a monochorionic twin pregnancy: case report. Ultrasound Obstet Gynecol. 2007 Apr;29(4):453-6. doi: 10.1002/uog.3967.

  PMID: 17390325 BACKGROUND

• Merhar SL, Kline-Fath BM, Meinzen-Derr J, Schibler KR, Leach JL. Fetal and postnatal brain MRI in premature infants with twin-twin transfusion syndrome. J Perinatol. 2013 Feb;33(2):112-8. doi: 10.1038/jp.2012.87. Epub 2012 Jun 28.

  PMID: 22743408 BACKGROUND

• Inder TE, Anderson NJ, Spencer C, Wells S, Volpe JJ. White matter injury in the premature infant: a comparison between serial cranial sonographic and MR findings at term. AJNR Am J Neuroradiol. 2003 May;24(5):805-9.

  PMID: 12748075 BACKGROUND

• Woodward LJ, Anderson PJ, Austin NC, Howard K, Inder TE. Neonatal MRI to predict neurodevelopmental outcomes in preterm infants. N Engl J Med. 2006 Aug 17;355(7):685-94. doi: 10.1056/NEJMoa053792.

  PMID: 16914704 BACKGROUND

• Inder TE, Wells SJ, Mogridge NB, Spencer C, Volpe JJ. Defining the nature of the cerebral abnormalities in the premature infant: a qualitative magnetic resonance imaging study. J Pediatr. 2003 Aug;143(2):171-9. doi: 10.1067/S0022-3476(03)00357-3.

  PMID: 12970628 BACKGROUND

• Woodward LJ, Mogridge N, Wells SW, Inder TE. Can neurobehavioral examination predict the presence of cerebral injury in the very low birth weight infant? J Dev Behav Pediatr. 2004 Oct;25(5):326-34. doi: 10.1097/00004703-200410000-00004.

  PMID: 15502549 BACKGROUND

MeSH Terms

Conditions

Fetofetal Transfusion; Developmental Disabilities

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Catherine Cibulskis, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: September 30, 2020
• Study Completion: May 30, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

US (1)