Clinical Research Directory

High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia

This study is a prospective, single center and observational open clinical study.

Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT/OT Caregiver "Primer" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy

This study focuses on the caregiver's knowledge, comfort, and confidence in interacting with and supporting their infant with Cerebral Palsy (CP) or at high risk for Cerebral Palsy. Four caregivers with their infants will be in one cohort to assess the benefits of group intervention. The intervention is delivered in a group, bootcamp-style educational format led by clinical team including pediatric physiatrist, physical therapist and occupational therapist.

Optimizing Tracheal Intubation Outcomes and Neonatal Safety

The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation procedural safety and clinical outcomes among patients intubated in the neonatal intensive care unit (NICU) setting.

Outpatient Pediatric Pulse Oximeters in Africa

The primary objective of this clinical trial is to evaluate the performance of three pulse oximeters during outpatient care within Cape Town, South Africa. This objective will be achieved through generating evidence on how, why, for whom, to what extent and at what cost can paediatric pulse oximetry devices improve the management of hypoxemic children. This will be done with two inter-linked studies: * Aim 1: Determine the impact of two novel paediatric pulse oximeter devices on the correct management of hypoxaemia. * Aim 2: Describe the burden of hypoxaemia and risks for mortality amongst children presenting with acute respiratory infections in a low-resource setting in Cape Town.

The prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

The purpose of this study is to conduct a randomized controlled trial among 800 socially disadvantaged pregnant women and their families to test the effectiveness of a multi-component home visitation nutrition program, compared to usual care, in promoting healthy feeding practices, lifestyle behaviors and growth in young children.

Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.

This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits. Parents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.

Comparison of the Effectiveness of Face to Face Rehabilitation and Telerehabilitation in Infants With Congenital Muscular Torticollis

Who is this study for? This study is designed for infants aged 0-6 months who have been diagnosed with Congenital Muscular Torticollis (CMT). CMT is a condition observed at birth or shortly after, characterized by the shortening of the sternocleidomastoid (SCM) muscle, leading to the baby's head tilting to one side and rotating to the opposite side. It affects both boys and girls and may result in limited neck movement, abnormal posture, facial asymmetry, and potential developmental delays if left untreated. What is the purpose of this study? The goal of this study is to compare the effectiveness of two different physical therapy methods-face-to-face rehabilitation and telerehabilitation-in treating infants with CMT. In addition to evaluating the outcomes of these two therapy methods, this research also aims to provide families with reliable, accessible information through a web-based educational platform. Why is this study important? Early diagnosis and intervention are crucial for optimal recovery in infants with CMT. Studies show that infants who begin therapy by one month of age have up to a 98% chance of full recovery. However, if diagnosis and treatment are delayed, the recovery process can take longer and may be less effective. This study will help determine if online (telerehabilitation) sessions can be just as effective as traditional face-to-face therapy, offering a flexible and accessible treatment option for families. What are the benefits of participating? * Access to a structured, evidence-based rehabilitation program for your child * Guidance from trained pediatric physiotherapists * Increased awareness and knowledge about CMT through a web-based family education platform * Contribution to research that may benefit other children and families in the future * Evaluation of your baby's progress through professional assessments What will the therapy program involve? Participants will be randomly assigned to either a face-to-face or telerehabilitation group. Both groups will follow the same therapy program, focusing on: * Increasing passive and active neck movements * Promoting symmetrical head and body movement * Providing recommendations for environmental adjustments * Educating parents or caregivers on home-based exercises and care Program structure: * Face-to-face group: Therapy sessions will be conducted in a clinic setting, twice a week for 30 minutes each session, over a period of 8 weeks. * Telerehabilitation group: Therapy sessions will be conducted via Zoom, with the same frequency, duration, and content as the face-to-face sessions. How will outcomes be measured? Infants will be assessed before and after the 8-week therapy period for: * Passive cervical range of motion (rotation and lateral flexion) * Gross motor function * Muscle function Parental adherence to the home program will also be evaluated through a questionnaire. A follow-up will be conducted one month after therapy ends. How can I participate? If your infant is aged 0-6 months and has been diagnosed with CMT, you may be eligible to participate. You will need access to a device with internet for telerehabilitation sessions, if assigned to that group. Participation is voluntary and free of charge. Families will receive detailed instructions and ongoing support throughout the program. Additional Resources: As part of this study, a web-based educational platform will be made available to all participating families. This platform will include: * Clear explanations about CMT * Instructional videos and home exercise guides * Tips for daily care and positioning * Frequently asked questions (FAQ) for parents Why is this research unique? This is one of the first studies to scientifically compare face-to-face and online rehabilitation for CMT infants, while also providing a reliable online resource for families. It aims to help develop alternative, flexible care models that meet the diverse needs of families and infants. Contact Information: If you are interested in participating or would like more information, please contact our research team at: \[fgokcenalaca@gmail.com / +905534646606\] We are committed to supporting your child's health and development. Thank you for considering being a part of this important study.

Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years

This study will investigate if the dosage of veinous lactate at the end of a surgical procedure is related to post-operative complications occurring within 3 months in young infants aged 0-1 years. Blood samples are acquired routinely before emergence of general anesthesia, from the IV line put in place for anesthesia. The investigators hypothesized that elevated lactates would be associated with more postoperative complications in this population, as is the case in adults.

Latin American Surgical Outcomes Study in Pediatric Patients

This prospective, international, multicenter observational study will include hospitals performing pediatric surgery in participating Latin American countries. We aim to assess the incidence of hospital postoperative complications in pediatric surgical patients \< 18-years-old in Latin America. We will recruit all consecutive pediatric patients under the age of 18 years who were admitted to participating hospitals undergoing elective and nonelective surgery. The primary outcome is in-hospital postoperative complications up to 30 days after surgery.

Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial

The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.

Family Centred Healthcare - Zero Separation and Couplet Care

Today mother and infant are routinely separated directly after birth if there is a need of specialised treatment and care, despite of the significant and positive effects of skin-to-skin contact. Thus, there is a need of change in organizing the treatment and care in a way that minimizes separation. The aim is to evaluate the implementation and effect of a complex family-centred intervention based 107 on zero separation and couplet care. The intervention is rooted in the philosophy of family-centred care. Essentially, mother infant dyads will be admitted together, where they will receive couplet care by neonatal nurses. The study comprises a quasi-experimental trial and a qualitative process evaluation including a field study and two interview studies. Finally, a health economic evaluation will be conducted to assess the cost-effectiveness of this complex intervention. The intervention will take place at the Neonatal Intensive Care Unit at Hvidovre Hospital. The nurses will as a part of the intervention be educated to take care of both mother and infant and carry out the intervention. Five families with experiences from the Neonatal Intensive Care Unit and the Maternity Unit participates as patient and public representative in the project, as their experiences and ideas will provide an added value to the project. This study contribute with a new perspective on how to organize the treatment and care of a newborn family in a Neonatal Intensive Care Unit. The study will be the first to examine zero separation and couplet care within sick mother-infant dyads. The study will provide knowledge about how an intervention consisting of zero separation and couplet care can be feasible and acceptable, and what kind of effect and impact it will provide. It is expected that the study as a whole may impact and profile clinical nursing, as well as benefitting public health.

Validation of the GoCheck Kids® Eye Screeningtest in Infants in Flanders

The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (\<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study.