Clinical trials: Intensive Care, Neonatal
Preterm Birth, Very Preterm Infant
NICU-to-Home Dyadic Support for Very Preterm Infants and Families
This feasibility study will evaluate delivery of the Supporting Play Exploration and Early Development Intervention after neonatal intensive care unit discharge for very preterm infants and their families.
- Conditions
- Preterm Birth, Very Preterm Infant, Infant Development, Neonatal Intensive Care Unit
- Trial name
- MN-SPEEDI (NCT07820462)
- Testing
- Homebased SPEEDI, Telehealth SPEEDI
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Minnesota
Persistent Pulmonary Hypertension, Mechanical Ventilation Strategies
Pressure Regulated Volume Control Ventilation in Neonates Persistent Pulmonary Hypertension
This study aims to assess the clinical and respiratory outcomes of Pressure-Regulated Volume Control ventilation as compared with patient on pressure-controlled ventilation in neonates with persistent pulmonary hypertension.
- Conditions
- Persistent Pulmonary Hypertension, Mechanical Ventilation Strategies, Neonatal Intensive Care Unit (NICU), Ventilation
- Trial name
- NCT07850908
- Testing
- Pressure-Controlled Ventilation, Group II (Pressure-Regulated Volume Control)
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Tanta University
Digital Health, Maternal Health Services
The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care
DED 2.0 is a stepped-wedge cluster-randomized trial testing whether an integrated digital health ecosystem (KuApps, a service-monitoring dashboard, AI-assisted OCR for handwritten records, two-way WhatsApp-based health…
- Conditions
- Digital Health, Maternal Health Services, Prenatal Care, Intensive Care, Neonatal
- Trial name
- DED (NCT07842224)
- Testing
- Digitally Enabled District (DED)
- Where
- Indonesia
- Volunteers
- 10,800 people, healthy volunteers welcome
- Sponsor
- Summit Institute for Development, Indonesia
Neonatal Intensive Care Unit (NICU)
Effects of TUMATA and Mozart Music on Sleep and Comfort in NICU Newborns
This study aims to evaluate the effects of two different types of music played in the neonatal intensive care unit on newborns' sleep and comfort levels.
- Trial name
- NeoMusic (NCT07837180)
- Testing
- TUMATA Music, Mozart Classical Music
- Where
- Turkey (Türkiye)
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Karamanoğlu Mehmetbey University
Psychological Flexibility, Psychological Distress
ACT-Based Counseling to Improve Psychological Flexibility in Mothers of Infants Hospitalized in the NICU
This randomized controlled trial will evaluate two Acceptance and Commitment Therapy (ACT)-based counseling approaches for mothers whose infants are hospitalized in a Neonatal Intensive Care Unit (NICU).
- Conditions
- Psychological Flexibility, Psychological Distress, Neonatal Intensive Care Unit, Acceptance & Commitment Therapy
- Trial name
- NICU-ACT (NCT07837609)
- Testing
- ACT-Based Online Psychoeducational Workshop, ACT-Based Chatbot Counseling
- Volunteers
- 135 people
- Sponsor
- Meserret Aslan
Premature, Neonatal Intensive Care Unit
The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns
Premature infants frequently experience painful procedures during their admission to neonatal intensive care units; this can lead to acute adverse events, imbalances, and long-term neurodevelopmental implications.
- Conditions
- Premature, Neonatal Intensive Care Unit, Touch, Nursing Care
- Trial name
- NCT07715682
- Testing
- Gentle Human Touch, Environmental Modification
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Kubra Nur Kabakcı Sarıdağ
Premature, Phototherapy
Effectiveness of Aluminum Foil vs White Linen Reflectors in Phototherapy for Neonatal Hyperbilirubinemia
Background: Indirect hyperbilirubinemia (IHB) is a common neonatal condition, affecting over 60% of term and 80% of preterm infants.
- Conditions
- Premature, Phototherapy, Neonatal Intensive Care Unit, Neonatal Hyperbilirubinemia
- Trial name
- NCT07266246
- Testing
- reflective material
- Where
- Turkey (Türkiye)
- Volunteers
- 81 people
- Sponsor
- Kubra Nur Kabakcı Sarıdağ
Neonatal Hypoglycemia, Metabolic Complication
Pasteurised Donor Human Milk Supplementation for Term Babies
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in…
- Conditions
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay
- Trial name
- PRESENT (NCT06993103)
- Testing
- Standard care Cow's milk based formula, Dietary Supplement: PDHM Pasteurised Donor Human Milk
- Where
- 4 sites in Australia
- Volunteers
- 1,444 people
- Sponsor
- The University of Queensland
Infant Admitted to Neonatal Intensive Care Unit (NICU)
The Effects of a Caregiver-initiated Reading Intervention to Their Infant in the Neonatal Intensive Care Unit
The purpose of this study is to investigate the impact of a caregiver-initiated reading intervention to their infant, in the Neonatal Intensive Care Unit (NICU), on the caregiver-infant dyad, both during hospitalization and…
- Trial name
- NCT07789145
- Testing
- Reading Intervention
- Volunteers
- 120 people
- Sponsor
- University of Texas Southwestern Medical Center
Premature Infant, Clustered Care
Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
The Individualized Developmental Care (IDC) model was developed to minimize the negative impact of the neonatal intensive care environment and to support infants' physiological stability.
- Conditions
- Premature Infant, Clustered Care, Neonatal Intensive Care Unit, Developmental Care
- Trial name
- Guideline (NCT07052786)
- Testing
- Infants will receive group care based on individualized developmental care according to the guide., Standard care
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- KTO Karatay University
Nutrition Disorders, Gastrointestinal Disease
Review of Infant Oral Feeding and Skills
This study evaluates the infant's feeding skill level at discharge from the neonatal intensive care unit. The goal is to determine whether the ability to "full feed by volume" implies "full skill development" for infant oral…
- Conditions
- Nutrition Disorders, Gastrointestinal Disease, Deglutition Disorder, Feeding Difficulties
- Trial name
- RIOS (NCT06736743)
- Testing
- SMART Tool for Feeding Skill Assessment
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Wake Forest University Health Sciences
Neonatal Intensive Care Unit, Hospitalized Newborn
Maternal Sensory Interventions in Newborns
This study was designed to determine the effects of maternal sensory interventions (kangaroo care, lullabies, and maternal tactile-auditory soothing) on sleep-wake states, physiological parameters, and sleep onset latency in…
- Trial name
- MSI (NCT07725094)
- Testing
- Kangaroo Care, Maternal Lullaby, Maternal Tactile-Auditory Soothing
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Kirsehir Ahi Evran Universitesi
Preterm Infant, Infant, Premature
Pilot Study of the SENSITIVE Care Program for Preterm Infants in the Neonatal Intensive Care Unit
The goal of this clinical trial is to learn whether the Sensory Integrative Intervention (SENSITIVE) Care Program helps reduce stress and improve mother-infant interaction in preterm infants receiving care in the Neonatal…
- Conditions
- Preterm Infant, Infant, Premature, Neonatal Intensive Care Unit (NICU)
- Trial name
- SENSITIVE Care (NCT07728760)
- Testing
- SENSITIVE Care Program, Standard Neonatal Intensive Care
- Where
- Indonesia
- Volunteers
- 8 people
- Sponsor
- Gadjah Mada University
Neonatal Intensive Care Unit
Reducing Fluids Intakes in Neonatal Intensive Care
During stay in the neonatal intensive care unit, newborns requires various treatments administered intravenously. The hidden fluid intake associated with these infusion can lead to fluid overlad, increasing the risk of…
- Trial name
- REFINI (NCT07715513)
- Testing
- hidden fluid intake
- Where
- France
- Volunteers
- 9 people
- Sponsor
- University Hospital, Clermont-Ferrand
Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded
Neonatal Diaphragmatic Activity-Linked Extubation Conditions and Timing
The objective of this study is to evaluate the role of diaphragmatic electrical activity monitoring (collected by esophageal probe) around extubation of preterm patients in order to consider its use as a standardized objective…
- Conditions
- Study of Predictors of Successful Extubation in Preterm Infants, Extubation Succeeded, Extubation Failure, Preterm
- Trial name
- NEODIALECT (NCT07709988)
- Volunteers
- 20 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Infant, Extremely Premature, Obstetric Labor, Premature
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to…
- Conditions
- Infant, Extremely Premature, Obstetric Labor, Premature, Premature Birth, Intensive Care, Neonatal
- Trial name
- NCT05685745
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 5,000 people
- Sponsor
- The University of Texas Health Science Center, Houston
Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants
Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management.
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Surfactants, Intensive Care Units, Neonatal
- Trial name
- NCT06446453
- Testing
- Echography-guided Surfactant THERapy (ESTHER)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Connecticut Children's Medical Center
Neonatal Pain, Retinopathy of Prematurity (ROP)
Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants
The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm…
- Conditions
- Neonatal Pain, Retinopathy of Prematurity (ROP), Pain Management, Infant, Premature
- Trial name
- FIREFLY (NCT07112430)
- Testing
- Fentanyl Citrate (Intranasal)
- Where
- Canada
- Volunteers
- 58 people
- Sponsor
- Marsha Campbell-Yeo
Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature
The UK 22 Week Study
In the UK, babies born at 22 weeks of pregnancy have only been offered survival-focused care (sometimes called resuscitation or stabilisation) since 2019.
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions, Intensive Care, Neonatal
- Trial name
- NCT07616778
- Testing
- Not applicable (observational study)
- Where
- 50 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Imperial College London
Nursing Education, Simulation Based Learning
Effects of NICU Scenario-Based Simulation on Nursing Students' Perceived Stress, Satisfaction, Self-Confidence, and Learning: A Mixed-Methods Study
This mixed-methods study examines the effects of neonatal intensive care unit (NICU) scenario-based simulation training on third-year nursing students' perceived stress, learning satisfaction, self-confidence, and…
- Conditions
- Nursing Education, Simulation Based Learning, Stress, Psychological, Nursing Students
- Trial name
- NCT07653308
- Testing
- NICU Scenario-Based Simulation Training
- Where
- Turkey (Türkiye)
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Atılım University