Calmer Brains in Very Preterm Infants

ConditionPremature Infant

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age26-30

SponsorUniversity of British Columbia

About this trial

Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development. Calmer was invented to mimic key parts of parental holding (touch, heartbeat sounds and breathing motion) to help reduce stress if parents cannot be there to hold their infant. Using specialized brain scans done at full term, we will gather initial information in 22 infants born 3-4 months early to compare brain development in infants who receive Calmer at least 3 hours each day (+ regular NICU care) over 2-3 weeks with infants who have regular NICU care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Very preterm infants admitted to the NICU at the BC Women's Hospital

Disqualifiers

Congenital anomalies;

Born small for GA (per medical admission history);

History of birthing parent substance use in pregnancy;

Ongoing infection at the time of enrollment;

Trial design

Design model

Parallel

Treatments tested in this trial

Calmer
Device
Calmer, a unique, patented, therapeutic bed that mimics key aspects of SSC that reduce stress in preterm infants. Calmer fits into NICU incubators and cribs, and delivers 3 key SSC stimuli: touch, breathing motion, and heartbeat sounds; the rates of the latter 2 stimuli are individualized to each infant based on their parents' breathing and heart rates. Calmer is designed to provide complementary care only when parents are not able to give SSC. It is not meant nor designed to replace human SSC, so will never be tested as such a replacement. Instead, Calmer was invented to enhance and optimize brain development in preterm infants by reducing stress during the NICU stay, when parents/caregivers are not available for SSC. Our ultimate goal is to enable use of Calmer from an infant's admission to discharge, only during those times when caregivers are not available.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: CalmerExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Brain Volumes

Anatomical analysis: Anatomical images (T2w) will be manually inspected for quality control. Images with very poor tissue contrast or motion artefacts will be rejected. T2w images will be bias-field corrected using ANTs N4ITK. The images will then be skull-stripped and segmented using the dHCP anatomical pipeline to calculate total and sub-regional brain volumes.

Time frame

When each participant reaches 40 weeks post-conceptual age and return for their MRI scan

Brain Functional Connectivity

Resting state fMRI analysis: Fieldmaps will be generated using the dual-echo EPI and magnitude scan. The dHCP functional pipeline will be implemented to achieve distortion-correction and motion-correction, register the functional image to the corresponding T2w structural image, generate a transform matrix from functional space to the 40-week T2w template; and we will perform temporal high-pass filtering (150 s high-pass cutoff) and independent component analysis (ICA) denoising using ICA FIX. Scans with a mean FD \> 1 mm will be excluded. The dHCP functional pipeline will then be run on all subjects using the study-specific training file. Spatial smoothing of 5 mm will be applied using FSL's SUSAN and grand mean intensity normalization will be computed. Functional connectivity measures will be computed using the CONN toolbox.

Time frame

When each participant reaches 40 weeks post-conceptual age

Brain Fractional Anisotropy

Diffusion tensor imaging analysis: The dHCP neonatal dMRI data processing pipeline will be used to pre-process the diffusion weighted images. Briefly, opposite phase b0 images are used to estimate the off-resonance field that is then used in the simultaneous correction of motion artefacts, susceptibility-induced and eddy current distortions. Data will then be super-resolved and, after pre-processing is complete, local diffusion and microstructural models are fitted in every voxel and averaged to calculate mean fractional anisotropy.

Time frame

When participants reach term-equivalent age

Secondary outcomes

Clinical weight measures

Weight: infant weight in kilograms captured when enrolled in the study (i.e. baseline T1) and end of experimental phase (2-3 weeks later; T2) We will use the weight measure to determine changes between baseline and the end of treatment.

Time frame

From the start of study treatment (or enrolment if Control group) to 2-3 weeks later, at the end of intervention exposure.

Head growth measures

Head circumference: infant head circumference in centimetres (occipito-frontal circumference) captured when enrolled in the study (i.e. baseline T1) and end of experimental phase (2-3 weeks later; T2). We will use the head circumference measures to determine changes between baseline and the end of treatment.

Time frame

From the start of study treatment (or enrolment if Control group) to 2-3 weeks later, at the end of intervention exposure.

Other outcomes

Trial feasibility

Consent rate: overall average consent rate of infants/month

Time frame

2 years from the start of the study

Trial feasibility

Protocol delivery: % of on/off protocol infants

Time frame

2 years from the start of the study

Trial feasibility

Outcome measures: % of infants with complete primary outcome data

Time frame

2 years from the start of the study

Trial feasibility

Rate/nature of safety issues

Time frame

2 years from the start of the study

Sponsors and contacts

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University of British Columbia

Lead sponsor

BC Children's Hospital Research Institute

Collaborator

Source ClinicalTrials.gov

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