Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants

Launched by UNIVERSITY OF BRITISH COLUMBIA · May 27, 2021

Keywords

ClinConnect Summary

This clinical trial, called "Creating a Calmer NICU," is exploring a new therapy called Calmer, designed to help preterm infants who often face stress in the neonatal intensive care unit (NICU). The trial aims to see if using the Calmer therapy bed, which mimics the comforting touch and sounds of a parent, can improve physical growth and brain development in these infants. The study will involve 20 preterm babies born between 26 to 30 weeks of pregnancy, comparing the effects of Calmer therapy with standard NICU care over three weeks.

To participate, infants must be admitted to the NICU and receive respiratory support, such as a CPAP machine or ventilation. Parents or caregivers need to speak enough English to give consent. Throughout the trial, infants in the Calmer group will spend a minimum of three hours per day on the therapy bed, while the control group will continue with regular NICU care. The researchers will measure growth markers, like weight and head size, and brain activity to see how well the Calmer therapy works. This study is an important step in finding better ways to support the health and development of preterm infants during their critical time in the NICU.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Preterm infants admitted to the neonatal intensive care unit (NICU) at the British Columbia (BC) Women's Hospital born at 26-30 completed weeks gestational age (GA). GA is determined accurately using early gestation ultrasonogram (standard of care in BC), or calculated using the last menstrual period;
• • Infants who are on continuous positive airway pressure or are ventilated;
• • At least one parent/caregiver must speak sufficient English to provide consent
• Exclusion Criteria:
• • Infants who have congenital anomalies, small for GA (per medical admission history), or have a history of maternal abuse of controlled drugs and substances; - Infants with an ongoing infection at the time of enrolment;
• • Infants that have pre-existing cardiovascular instability defined by shock/hypotension/need for cardiovascular drugs
• • Infants receiving paralytic drugs;
• • Infants that have major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage/stroke);
• • Infants who are beyond the 30th completed week GA (30 weeks + 6 days) at enrolment.