Clinical Research Directory

Effects of White Noise and Lullaby on Vital Signs of Term Newborns in Neonatal Intensive Care

This clinical study aims to evaluate how two types of gentle sounds - white noise and a traditional Turkish lullaby ("Dandini Dandini Dastana") - affect the vital signs of term newborns cared for in the Neonatal Intensive Care Unit (NICU). The first weeks of life are critical for newborns, especially those who need special care in the NICU. During this time, maintaining physiological stability-such as normal heart rate, breathing rate, and oxygen levels-is essential. In addition to medical treatments, non-pharmacological interventions like music and soothing sounds are increasingly used to reduce stress and support comfort. In this randomized controlled study, 70 term newborns (born after 37 weeks of gestation and weighing at least 2500 grams) were randomly assigned to one of two groups: * White Noise Group: infants listened to a digitally recorded white noise (imitating intrauterine sound patterns) for 20 minutes. * Lullaby Group: infants listened to a recording of the traditional lullaby "Dandini Dandini Dastana" for the same duration. Both interventions were administered three times a day for four consecutive days in a calm NICU environment. The sound level was carefully calibrated not to exceed 55 decibels (dBA), ensuring safety for newborn hearing. Researchers measured heart rate, respiratory rate, and oxygen saturation (SpO₂) at baseline and at the 5th, 10th, 15th, and 20th minutes during each session. Results showed that both white noise and lullaby sessions led to a gradual decrease in heart rate, while breathing rate and oxygen levels remained stable. No adverse events or signs of physiological instability were observed. These findings suggest that both white noise and lullaby listening are safe, low-cost, and effective supportive methods for helping term newborns remain calm and physiologically stable during intensive care. The study contributes to growing evidence that structured auditory stimulation can help promote comfort and self-regulation in newborns without the need for medication.

Improving Artificial Intelligence-derived Algorithms for Estimating Length and Weight in NEonateS and infanTs up to 6 Months of Age (NEST)

The NEST study is a prospective, observational research study designed to collect clinical measurements and image data to develop and evaluate artificial intelligence (AI)-derived algorithms for estimating anthropometric parameters in neonates and young infants. The study focuses on infants from birth up to 6 months of age and aims to assess the accuracy of AI-based estimations of length, weight, and head circumference using photographs and/or video recordings captured during routine clinical care. These AI-derived measurements will be compared against standard clinical measurements obtained by trained healthcare professionals in neonatal and infant care settings.

Chest X-Rays for Early Detection of Congenital Heart Disease in Newborns

Congenital heart disease (CHD) is a common condition affecting newborns that can be serious if not caught early. While echocardiograms are the best way to diagnose CHD, they are not always immediately available. Chest X-rays are widely available and are often the first test used when a newborn has breathing problems, a heart murmur, or a bluish skin tint. The purpose of this study is to determine how accurate standard chest X-rays are at finding congenital heart disease in newborns. Researchers will observe 60 newborns (up to 28 days old) admitted to the Neonatal Intensive Care Unit (NICU) who have signs or symptoms that suggest they might have a heart problem. Each baby in the study will receive a standard chest X-ray within 24 hours of their clinical presentation. Within 72 hours, they will also receive an echocardiogram, which is the standard, definitive test used to confirm if there is a heart defect. By comparing the initial chest X-ray results to the final echocardiogram results, researchers hope to figure out exactly which X-ray patterns are best at predicting specific heart diseases. This could help doctors make faster decisions about treating newborns, potentially reducing delays in diagnosis and improving care.

Upper Airway Ultrasound to Predict Difficult Laryngoscopy in Neonates and Infants

Upper airway ultrasound (UA-US) has been utilized in adults to predict difficult laryngoscopy (Cormick-Lehane view 3 or 4) and difficult tracheal intubation (DTI) (≥3 intubation attempts) and with moderate-to-high sensitivity and specificity. This bedside technique is reproducible, easy-to-do without any additional radiation risk, and was added to the most recent American Society of Anesthesiologists (ASA) Practice Guidelines for Difficult Airway Management in Adults. However, UA-US has only been applied to older children ages 5-12 and has not been examined in neonates and infants. Thus, the aim of this observational study using UA-US to predict difficult laryngoscopy and tracheal intubation in neonates and infants presenting for diagnostic, procedural or surgical care under general anesthesia requiring endotracheal intubation.

Music Therapy During Hypothermia in the NICU

Background: Hypoxic-ischemic encephalopathy (HIE) is a neurological condition caused by poor oxygenation during the peripartum period. The main strategy to mitigate neurological damage is hypothermic therapy (HT), whose effectiveness-among other factors-depends on adequate pain management. Considering the prevalence of allodynia in this group of patients, routine nursing procedures can become sources of additional stress and pain. Music therapy is used in this population to promote self-regulation and relaxation, and may therefore help reduce pain levels after routine nursing procedures. Research question: What is the effect of an entrainment-based live music therapy intervention on pain levels in newborns with hypoxic-ischemic encephalopathy undergoing hypothermic therapy after routine nursing procedures? Methodology: A randomized, crossover pilot and feasibility study. Participants will be 22 newborns admitted to the Neonatal Intensive Care Unit (NICU) of the University Hospital Fundación Santa Fe de Bogotá. Participants will receive standard care plus a 15-minute live music therapy session after a routine nursing procedure, or standard care alone. The primary outcome is the Premature Infant Pain Profile-Revised (PIPP-R) scale, which will be assessed through video recordings. Secondary outcomes are vital signs, heart rate variability, and electroencephalography (EEG) recordings. Expected outcomes: Through this study, the aim is to improve the comfort and well-being of patients with HIE during TH. In addition, the safety and feasibility of music therapy in this population will be evaluated, seeking to contribute to current knowledge about the mechanisms of music therapy.

Predictive Value of Scoring System in Neonates with Disseminated Intravascular Coagulation

The aims of this study were to investigate underlying diseases associated with neonatal DIC diagnosed on the first 28 days of life, and whether DIC score could predict mortality in neonates.

Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy

The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy.