Clinical Research Directory

Effects of Early Physiotherapy Program on the Infants in NICU

High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems. This heterogeneous group encompasses premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various causes.Studies have highlighted that individual developmental care, family education, kangaroo care, and early physiotherapy approaches applied to at-risk infants in the neonatal intensive care unit (NICU) enhance infant development. However, further research is needed to determine the most effective interventions for infants who are more environmentally at risk and biologically vulnerable. Studies investigating the effectiveness of early intervention methods initiated in the NICU on the motor, cognitive, and behavioral outcomes of premature infants have highlighted that postural control interventions or physiotherapy consisting of developmental care programs implemented in the neonatal period improve motor development in the short term, but parent-implemented motor interventions are more effective in improving infants' cognitive and motor outcomes in the long term.The aim of this study is to examine the effects of family-based early physiotherapy approaches applied to at-risk infants in the NICU on motor, cognitive, language development and developmental outcomes at term age and in the long term (adjusted 3, 6, 9, 12 months).

The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU

The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study. The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day. Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study.

Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project

This prospective single centre longitudinal cohort study enrols preterm infants ≤32+0 weeks of gestation and/or birthweight ≤1500g and their parents. Following a baseline period additional Family Centred Care elements are introduced as potentially better practices, these elements focus on four areas: the NICU (Neonatal Intensive Care Unit) environment, staff training, parental education and psychosocial support to the families. The effect of the implementation of additional Family Centred Care elements on infant, parent and staff outcomes are assessed. The parallel data collection enables to study the interrelation between these three important areas of research.

Family Centered Care Cohort Study 1 in Nagano Children's Hospital

An observational cohort study to show the effect of parents' presence beside their infants, skin-to-skin contact (SCC), participation in infant care, or any interaction with their infants on parents' and infants' short- and long-term outcomes. Investigators create a hypothesis that longer parents' presence, SCC, participation in infant care, and any interaction with their infants affect outcomes of infants and parents by preventing parents' depression and promoting parent-infant bonding and, in addition, by shortening the length of stay, promoting growth, promoting establishment breastfeeding, and improving developmental outcomes. Parents are asked to make a record of the length of their presence, SCC, participation in infant care, and any interaction with their infants, which are quantitative measurements of family centered care (FCC). Investigators also collect the data related to the background information of the family, delivery, the clinical course of infants, and the outcome measures of the infants and parents. No intervention is included in this research. The study setting is a level IV neonatal intensive care unit (NICU) at Nagano Children's Hospital in Nagano, Japan. Eligible infants are those who are born at 34 weeks of gestation or earlier from Japanese parents in Nagano Children's Hospital and need admission into NICU in the same hospital. Infants are excluded from this study if they have any major anomalies including suspicion of chromosomal disorder on admission, if at least one parent is Not Japanese, or if they do not survive until discharge home. The primary outcomes are the EPDS and Japanese version of Mother-to-Infant Bonding Scale (MIBS-J) of the parents. The secondary outcomes are the followings; (1) length of stay (days), (2) physical measurements at 36 weeks (g or cm) and growth rate from birth to discharge home (g or cm /d), (3) breastmilk-feeding (exclusive, partial, or no breast milk) and the frequency of breastfeeding directly from breast at 36 weeks PMA and at discharge (average frequency per day), and for the infants whose birth weight \<1500g only, (4) developmental quotient (DQ) at 6 and 18 months of corrected age, and 3 years old assessed by Kyoto Scale of Psychological Development (KSPD).

Close Collaboration and Discharge Readiness

This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness. The intervention is planned to be implemented between December 2023 and December 2024. The investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.

Effects of Parents Included in Medical Round of Neonatal Intensive Care Unit

The goal of this cross-over randomized controlled study is to evaluate the effects of medical rounds with parents. The main questions it aims to answer are: * How feasible the protocol of this study is to include parents in the medical round? * Does the Family Round promote the quality of family centered care in the NICU perceived by parents and healthcare staff? * Does the Family Round promote parent-infant bonding? * Does the Family Round reduce parents' anxiety? * Does the Family Round increase parents' satisfaction? * Does the Family Round improve staff's communication skills to integrate parents in the discussion of medical rounds? Participants will participate in the Family Round for two weeks, which is organized by healthcare staff following a protocol aiming to integrate parents into the discussion. They will be compared to the two-week period without the Family Round.