Serial Brain MRI in Hospitalized Preterm Infants

NCT06052865 | Active Not Recruiting

• 1 other identifier: 2019P003819
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to use serial magnetic resonance imaging (MRI) to define the timing and factors associated with brain injury as well as the pattern of brain growth of very preterm infants during hospitalization in the neonatal intensive care unit (NICU). In addition, the goal is to utilize early MRI to risk-stratify preterm infants and tailor rehabilitative interventions according to risk in order to explore associations between NICU rehabilitative intervention and short- and long-term outcomes of preterm infants.

Conditions

Preterm Birth Complication

Keywords

preterm; brain injury; neonatal rehabilitation

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of brain injury on term equivalent brain MRI in very preterm infants

  Term equivalent brain MRIs will be assessed to characterize brain injury, including elements of: white matter abnormalities, cortical gray matter abnormalities, deep gray matter abnormalities, and cerebellar abnormalities. A total (global) brain injury score will be calculated as the sum of regional brain abnormalities total scores, with higher scores indicating more advanced level of injury as per the established scoring system for hospitalized preterm infants published by Kidokoro et al. The score will reveal the following categories for brain injury: no injury (total score 0-3), mild injury (score 4-7), or moderate-severe injury (total score 8 or above).

  3 months, average length of hospitalization for very preterm born infants

• Incidence and severity of white matter injury on early brain MRI before term-equivalent age for very preterm infants

  Enrolled infants will undergo at least 2 early brain MRIs before term-equivalent age during the NICU hospitalization. Presence or absence of white matter injury on early brain MRIs will be categorized as follows: normal (no white matter lesions), minimal (3 or fewer areas of T1 signal abnormality), or moderate-severe (\> 3 areas of T1 signal abnormality)

  3 months, average length of hospitalization for very preterm born infants

Secondary Outcomes (5)

• Standardized assessment of developmental performance across multiple areas (cognitive, language, motor) at 2 years corrected age

  Up to 2 years corrected age

• Parent-reported child developmental performance (optional parent questionnaire)

  Up to 2 years corrected age

• Parent-reported child risk for autism (optional parent questionnaire)

  2 years corrected age

• Incidence of parental stress (optional parent questionnaire)

  Up to child's 2 years corrected age

• Parent sense of competency (optional parent questionnaire)

  Up to child's 2 years corrected age

Study Arms (3)

Exposed: High neurological risk

EXPERIMENTAL

25 very preterm infants with advanced neurological injury

Behavioral: SENSE-plus: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program

Exposed: Low neurological risk

EXPERIMENTAL

25 very preterm infants with low/no neurological injury

Behavioral: SENSE: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program

Reference/ Standard of care

OTHER

25 very preterm infants with no study exposure/ standard of care

Other: Reference/ Standard of care

Interventions

SENSE-plus: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program BEHAVIORAL

The SENSE II program was developed to engage parents in consistently providing positive, developmentally appropriate sensory exposures to their high-risk infants in the NICU every day of hospitalization. The SENSE II program includes specific doses and targeted timing (based on postmenstrual age) of evidence-based interventions of auditory, tactile, vestibular, kinesthetic, olfactory, and visual exposures to be conducted daily through hospitalization for preterm infants. Additionally, for very preterm infants with advanced neurological injury, additional 1-2 sessions of weekly motor therapy are added to the SENSE-II program

Also known as: SENSE-plus

Exposed: High neurological risk

SENSE: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program BEHAVIORAL

The SENSE II program was developed to engage parents in consistently providing positive, developmentally appropriate sensory exposures to their high-risk infants in the NICU every day of hospitalization. The SENSE II program includes specific doses and targeted timing (based on postmenstrual age) of evidence-based interventions of auditory, tactile, vestibular, kinesthetic, olfactory, and visual exposures to be conducted daily through hospitalization for preterm infants.

Also known as: SENSE

Exposed: Low neurological risk

Reference/ Standard of care OTHER

Infants in the Unexposed group receive the NICU standard of developmental care throughout hospitalization.

Also known as: NICU care

Reference/ Standard of care

Eligibility Criteria

• Age: 22 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• currently admitted to the BWH NICU
• born before 33 weeks completed gestational age
• birth weight 0.5-4.5 kg
• is stable condition per clinical care team

You may not qualify if:

• confirmed or suspected congenital anomaly or genetic syndrome
• congenital TORCH infection

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• POM Wonderful LLC: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• Pineda R, Wallendorf M, Smith J. A pilot study demonstrating the impact of the supporting and enhancing NICU sensory experiences (SENSE) program on the mother and infant. Early Hum Dev. 2020 May;144:105000. doi: 10.1016/j.earlhumdev.2020.105000. Epub 2020 Mar 6.

  PMID: 32151905 BACKGROUND

• Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.

  PMID: 15060237 BACKGROUND

• Pineda RG, Neil J, Dierker D, Smyser CD, Wallendorf M, Kidokoro H, Reynolds LC, Walker S, Rogers C, Mathur AM, Van Essen DC, Inder T. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. J Pediatr. 2014 Jan;164(1):52-60.e2. doi: 10.1016/j.jpeds.2013.08.047. Epub 2013 Oct 17.

  PMID: 24139564 BACKGROUND

• Pineda R, Raney M, Smith J. Supporting and enhancing NICU sensory experiences (SENSE): Defining developmentally-appropriate sensory exposures for high-risk infants. Early Hum Dev. 2019 Jun;133:29-35. doi: 10.1016/j.earlhumdev.2019.04.012. Epub 2019 May 1.

  PMID: 31054467 BACKGROUND

• Thiim KR, Singh E, Mukundan S, Grant PE, Yang E, El-Dib M, Inder TE. Clinical experience with an in-NICU magnetic resonance imaging system. J Perinatol. 2022 Jul;42(7):873-879. doi: 10.1038/s41372-022-01387-5. Epub 2022 Apr 22.

  PMID: 35459908 BACKGROUND

• Matthews LG, Walsh BH, Knutsen C, Neil JJ, Smyser CD, Rogers CE, Inder TE. Brain growth in the NICU: critical periods of tissue-specific expansion. Pediatr Res. 2018 May;83(5):976-981. doi: 10.1038/pr.2018.4. Epub 2018 Feb 7.

  PMID: 29320484 BACKGROUND

• Dyet LE, Kennea N, Counsell SJ, Maalouf EF, Ajayi-Obe M, Duggan PJ, Harrison M, Allsop JM, Hajnal J, Herlihy AH, Edwards B, Laroche S, Cowan FM, Rutherford MA, Edwards AD. Natural history of brain lesions in extremely preterm infants studied with serial magnetic resonance imaging from birth and neurodevelopmental assessment. Pediatrics. 2006 Aug;118(2):536-48. doi: 10.1542/peds.2005-1866.

  PMID: 16882805 BACKGROUND

• Kidokoro H, Anderson PJ, Doyle LW, Woodward LJ, Neil JJ, Inder TE. Brain injury and altered brain growth in preterm infants: predictors and prognosis. Pediatrics. 2014 Aug;134(2):e444-53. doi: 10.1542/peds.2013-2336.

  PMID: 25070300 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Brain Injuries

Interventions

Standard of Care; Intensive Care Units, Neonatal

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Intensive Care Units, Pediatric; Intensive Care Units; Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Carmina Erdei, MD

  Brigham and Women's Hospital and Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 25, 2023
• Study Start: September 14, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 14, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)