Clinical trials: Intensive Care, Neonatal
Family Relationship, Stress
Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes
The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Family Relationship, Stress, Breastfeeding, Bottle Feeding
- Trial name
- NCT02901665
- Testing
- FCC intervention
- Where
- 2 sites in United States
- Volunteers
- 191 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Premature Birth of Newborn, Family
GPS (Giving Parents Support): Parent Navigation After NICU Discharge
BACKGROUND: Annually >400,000 US newborns require neonatal intensive care unit (NICU) care.1/3 will require ongoing or specialty care after discharge.
- Conditions
- Premature Birth of Newborn, Family, Immature Newborn, Newborn Morbidity
- Trial name
- GPS (NCT02643472)
- Testing
- Parent Navigator, Care Notebook
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Children's National Research Institute
Intra-Abdominal Hypertension
Intra-Abdominal Hypertension in Neonatal Intensive Care Patients
The observational study is designed to determine the feasibility of performing Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in neonates who require bladder catheterization.
- Trial name
- NCT00747552
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Utah
Inguinal Hernia
Awake Caudal Catheter vs General Anesthesia
It is well established that preterm inguinal hernias discovered in the NICU pose a significant surgical risk due to the associated co-morbid conditions that accompany these patients.
- Trial name
- NCT05919732
- Testing
- Bupivacaine, Dexmedetomidine, Caffeine, Tylenol, Propofol, rocuronium, caffeine, Tylenol, bupivacaine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Nemours Children's Clinic
Premature Infants
A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management…
- Trial name
- NCT01994954
- Testing
- RHO
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- University of Massachusetts, Worcester
Neonatal Neuroimaging
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield)
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations.
- Trial name
- NCT02785588
- Testing
- 3.0 T Neonatal MRI scanner
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Infection
Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination
- Trial name
- NCT03728608
- Testing
- Feeding tube dwell time of 48 hours, Feeding tube dwell time of 7 day
- Where
- United States
- Volunteers
- 151 people
- Sponsor
- University of Florida
Neonatal Abstinence Syndrome
Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence Syndrome (NAS) treated with methadone with…
- Trial name
- NCT03134703
- Testing
- Methadone, Morphine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Johns Hopkins All Children's Hospital
Premature Infant Disease, Family Research
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU).
- Conditions
- Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy
- Trial name
- NCT04638127
- Testing
- PREEMIE PROGRESS, Attention Control
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Nurse Delivered Counseling, Emotional Distress
Listening Visits for Emotionally Distressed Mothers of Hospitalized Newborns
The proposed research has potential to dramatically improve care for emotionally distressed mothers of newborns hospitalized on the neonatal intensive care unit (NICU).
- Trial name
- NCT03704948
- Testing
- RCT Treatment -Listening Visits delivered by NICU nurse in person, RCT Control Usual mental health care delivered by NICU social workers, Open trial: Listening Visits delivered by a NICU nurse via zoom
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- University of Iowa
Abdominal Surgery, Thoracic Surgery
Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, and that neonates receiving…
- Trial name
- PNCA (NCT01823497)
- Testing
- Morphine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Medical College of Wisconsin
Genetic Diseases, Genetic Syndrome
Perinatal Precision Medicine
This study will seek to determine if rapid genomic sequencing improves outcomes for acutely ill infants. The investigator will enroll up to 1,000 acutely ill infants in a prospective, randomized, blinded study to either rapid…
- Conditions
- Genetic Diseases, Genetic Syndrome, Mendelian Disorders
- Trial name
- NSIGHT2 (NCT03211039)
- Testing
- Genomic sequencing and molecular diagnostic results, if any.
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- Rady Pediatric Genomics & Systems Medicine Institute
Respiratory Disorders, Intensive Care, Neonatal
Timing of Planned Caesarean Section and Morbidity of the Newborn
The caesarean section rate is rising globally. About 10% of the newborns are submitted to a neonatal department after planned caesarean section, primarily with respiratory disorders.
- Trial name
- NCT00835003
- Testing
- Elective caesarean section
- Where
- 7 sites in Denmark
- Volunteers
- 1,273 people
- Sponsor
- Aarhus University Hospital
Pulmonary Infections
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. Dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic…
- Trial name
- PVAIN (NCT01356147)
- Testing
- Dornase alfa
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Preterm Infants
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit…
- Trial name
- NCT03370757
- Testing
- 3-hour bundled care, 6-hour bundled care
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Duke University
Pediatric Disorder, Neonatal Disease
Neonatal Intensive Care Unit Virtual Family-Centered Rounds
The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.
- Trial name
- NCT05762835
- Testing
- Virtual family-centered rounds (FCR)
- Where
- United States
- Volunteers
- 514 people
- Sponsor
- University of California, Davis
Image Evaluation
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit
This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for imaging viable neonate and infant populations.
- Trial name
- Firefly (NCT02232009)
- Testing
- 3.0 T Neonatal MRI Scanner
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- GE Healthcare
Hypoxemia
Oxygen Saturation Alarms in the Neonatal Intensive Care Unit
Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will note the timing of oxygen saturation alarms, staff response, and interrupted staff activities.
- Trial name
- NCT01085539
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Cerebral Palsy, Sensorimotor Deficits
A Study of Neurophysiologically Based Occupational Therapy Intervention (NBOTI) for Feeding in the NCCU.
Many critically ill newborns in the neonatal intensive care (NICU) or critical care unit (NCCU) environment develop feeding and movement problems.
- Conditions
- Cerebral Palsy, Sensorimotor Deficits, Sensory Processing Disorder, Feeding Problems
- Trial name
- NBOTI (NCT00766051)
- Testing
- The intervention group: Neurophysiologically Based Occupational Therapy Intervention (NBOTI)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- University of Utah
Prematurity
A Clinical Trial of A Pacifier-Activated Music Player
Neonatal intensive care unit infants are at high risk for oromotor difficulties including poor coordination of sucking swallowing and breathing.
- Trial name
- NCT01600586
- Testing
- Pacifier-Activated-Lullaby system (PAL).
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Vanderbilt University Medical Center