Clinical trials: Newborn Care
Anemia
NeoSpHb Study: Can a Painless Device Detect Anaemia in Babies Without Blood Tests? A Study in the Neonatal Intensive Care Unit (NICU)
The goal of this study is to evaluate the diagnostic performance and feasibility of non-invasive spectrophotometric haemoglobin (SpHb) measurement for detecting anaemia in infants admitted to the Neonatal Intensive Care Unit…
- Trial name
- NeoSpHb (NCT07788703)
- Testing
- Spectrophotometry hemoglobin
- Where
- Malaysia
- Volunteers
- 30 people
- Sponsor
- University of Malaya
Respiratory Distress Syndrome
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
- Trial name
- NCT03058666
- Testing
- Aerosolized Calfactant, Solarys
- Where
- 22 sites in United States
- Volunteers
- 477 people
- Sponsor
- ONY
Neonatal Infection
Oral Amoxicillin and Cephalexin PK/PD in Neonates
The goal of this study is to figure out the best doses for two oral antibiotics (called amoxicillin and cephalexin) when they are used to treat infections in newborns and young infants.
- Trial name
- NCT04916951
- Testing
- Amoxicillin, Cephalexin
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Colorado, Denver
Self-efficacy
Using Smartphones in the Neonatal Intensive Care Unit
The goal of this research is to develop and pilot the NICU-2-Home service, a health information technology (IT) concept centered on a smart phone app.
- Trial name
- NCT01987180
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Northwestern University
Neonatal Neurobehavior
Effect of KMC on Neurobehavior of Preterm Neonates
This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least…
- Trial name
- NCT03740594
- Testing
- KMC
- Volunteers
- 120 people
- Sponsor
- Ain Shams University
Anxiety, Parents
The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in NICU
The aim of this study was to evaluate the effect of mandala painting activity on stress and anxiety levels in mothers whose babies were hospitalized in the neonatal intensive care unit (NICU).
- Conditions
- Anxiety, Parents, Psychological Stress
- Trial name
- NCT06499259
- Testing
- Mandala coloring
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Istanbul Medeniyet University
Neonatal Disorder
Soft Tissue Therapy in Managing Procedural Pain Among Neonates.
Effect of Soft tissue Therapy in managing Procedural Pain among neonates admitted in neonatal intensive care unit. This study focuses on the Procedural pain management with the help of Soft tissue manipulation which includes…
- Trial name
- NCT04309162
- Testing
- Soft tissue therapy
- Where
- India
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Asir John Samuel
Grief, Depressive Symptoms
Impact of a Neonatal-Bereavement-Support DVD on Grief
Experts agree that neonatal death has long-term impact on parents. Many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child.
- Trial name
- NCT01926080
- Testing
- DVD Intervention Arm
- Where
- United States
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Encephalopathy
Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy
The project aims at designing a machine learning solution able to recognize characteristics signals patterns of brain damages in full term babies born within a context of Hypoxic Ischemic Encephalopathy (HIE)
- Trial name
- NewbornDS (NCT05114070)
- Testing
- Decision of hypothermia
- Where
- France
- Volunteers
- 106 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Postpartum Complication, Postpartum
Postpartum Care in the NICU Multi-Site Breastfeeding
Parents of infants in the neonatal intensive care unit (NICU) face unique barriers to long-term breastfeeding and lactation. The physical and emotional demands of having a critically ill or premature newborn combined with the…
- Conditions
- Postpartum Complication, Postpartum, PTSD, PTSD (Childbirth-Related)
- Trial name
- PeliCaN (NCT07881731)
- Testing
- NICU-informed postpartum doula support
- Where
- 11 sites in United States
- Volunteers
- 640 people
- Sponsor
- Children's Hospital of Philadelphia
Preterm Infant, Hypothermia, Newborn
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known.
- Conditions
- Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care
- Trial name
- eKMC (NCT03555981)
- Testing
- Early Kangaroo Mother Care, Standard care
- Where
- The Gambia
- Volunteers
- 279 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Life Quality, Functional Status
Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life
This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life.
- Trial name
- NCT06290700
- Testing
- Neonatal Care education
- Where
- Turkey (Türkiye)
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Manisa Celal Bayar University
Seizure Recurrence
Mobile Video Education and Machine Learning-Based Risk Prediction in Neonatal Seizure Management
This mixed-methods study will develop a machine learning-based model to identify infants at high risk of seizure recurrence after discharge from the neonatal intensive care unit.
- Trial name
- NCT07695623
- Testing
- Mobile Video-Supported Education
- Volunteers
- 60 people
- Sponsor
- Istanbul Saglik Bilimleri University
Autosomal Dominant Hypocalcemia (ADH)
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
- Trial name
- CALIBRATE (NCT05680818)
- Testing
- Encaleret, Standard of Care
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 67 people
- Sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
Transition, Congenital Heart Defect
The Transitioning Rural Adolescents to Adult Care Study
Approximately 1 in 10 teenagers lives with a chronic health condition that will require ongoing care as they enter adulthood. Birth defects of the heart, also known as congenital heart disease (CHD) are more common than any other…
- Trial name
- TRAAC (NCT04090827)
- Testing
- Nurse-led transition intervention and access to the iHeartChange website
- Where
- Canada
- Volunteers
- 37 people
- Sponsor
- University of Alberta
Signs and Symptoms
Noninvasive Optical Measurement of Critical Care Neonates
The purpose of this study is to determine whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This study device is called laser speckle imaging.
- Trial name
- NCT01483703
- Testing
- Laser Speckle Imaging
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of California, Irvine
Cardiovascular Diseases, Hypertension
Implementing Digital Health in a Learning Health System
The need for new models of integrated care that can improve the efficiency of healthcare and reduce the costs are key priorities for health systems across the United States.
- Conditions
- Cardiovascular Diseases, Hypertension, Heart Failure, Atrial Fibrillation
- Trial name
- ASE-INNOVATE (NCT03713333)
- Testing
- Digital Health Device Diagnostics
- Where
- United States
- Volunteers
- 374 people
- Sponsor
- Scripps Health
Premature Birth
Listening to Mom 2: Neural, Clinical and Language Outcomes
The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born…
- Trial name
- NCT04193579
- Testing
- Language Treatment, Control Treatment
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Stanford University
Hypothermia, Newborn
Kangaroo Mother Care to Prevent Hypothermia in Preterm Infants
The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (<32.0…
- Trial name
- NCT02189746
- Testing
- Continuous Kangaroo Mother Care to 1 hour after birth, Standard Kangaroo Mother Care to 1 hour after birth, Continuous Kangaroo Mother Care to discharge
- Where
- Zambia
- Volunteers
- 140 people
- Sponsor
- University of Alabama at Birmingham
Post-Traumatic Stress Disorder, Psychological Trauma
The Effects of Trauma-informed Care Organization on Birth Professionals and Women's Experiences of Trauma.
This study aims to evaluate the effects of integrating trauma-informed care (TIC) into the organizational structure of maternity services on women giving birth and healthcare professionals involved in perinatal care.
- Trial name
- trauma-informe (NCT07823361)
- Testing
- trauma-informed care training
- Where
- Turkey (Türkiye)
- Volunteers
- 345 people
- Sponsor
- Tarsus University