Clinical trials: High-risk Infants
Birth Asphyxia
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.
- Trial name
- CEBA (NCT01743742)
- Testing
- Vitamin E, Vitamin C
- Where
- India
- Volunteers
- 95 people
- Sponsor
- Sir Takhtasinhji General Hospital
Neonatal Jaundice
Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
The purpose of this study is to determine the effect of 10 mg of oral zinc given daily between days 2 and 7 of life to term or near term neonates with serum bilirubin levels of more than 6 mg/dL at 24 ± 6 hours of life on…
- Trial name
- NCT00692224
- Testing
- zinc gluconate
- Where
- India
- Volunteers
- 294 people
- Sponsor
- All India Institute of Medical Sciences
Lingual Frenum, High Power Laser
Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
Ankyloglossia is an anomaly that is characterized by an abnormally short, thick or thin lingual frenulum that can restrict the movements of the tongue and has been identified as one of the factors that can negatively interfere…
- Conditions
- Lingual Frenum, High Power Laser, Breast Feeding
- Trial name
- NCT04487418
- Testing
- Electro cautery surgery, High power diode laser surgery
- Volunteers
- 56 people
- Sponsor
- University of Nove de Julho
Exposure to Secondhand Smoke in Neonatal Infants
Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes
A randomized, controlled, parallel group design will be used to test whether a Secondhand Smoke Exposure program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives…
- Trial name
- NCT01726062
- Testing
- Motivational Interviewing plus Incentives, Conventional Care (CC)
- Where
- United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Respiratory Distress Syndrome
High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome
To compare the primary outcome, failure of extubation defined by the need for re-intubation and mechanical ventilation within 5 days of initial extubation and secondary outcomes, morbidities and mortality after using of heated…
- Trial name
- NCT02587832
- Testing
- HHHFNC, NCPAP
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Sidra Medicine
Respiratory Distress Syndrome, Newborn, Chronic Lung Disease of Newborn (Diagnosis)
Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (CPAP) is one of the most commonly used tools but does not always…
- Trial name
- NCT03422549
- Testing
- Drager VN500 Ventilator
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of British Columbia
Neonatal Sepsis
Neonatal Sepsis Workup for High Risk Newborns - Evaluation of Need and Ways to Prevent
Sepsis is a significant cause of morbidity and mortality among newborns. Due to strict criteria and in order to diagnose and prevent early-onset group B streptococcal (EOGBS) sepsis, many infants undergo a sepsis workup due to…
- Trial name
- NCT02061150
- Where
- Israel
- Volunteers
- 800 people
- Sponsor
- Hillel Yaffe Medical Center
Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS).
- Conditions
- Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation, Nasal Continuous Positive Airway Pressure, Neonate
- Trial name
- NCT04905732
- Testing
- NHFOV, NCPAP
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Postnatal Growth Restriction
Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks'…
- Trial name
- NCT05403684
- Testing
- High-volume breastmilk
- Where
- Zambia
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Cystic Fibrosis
High Volumes of Hypertonic Saline and Chest Physiotherapy in CF Patients
Background Nebulised hypertonic saline (HS) is an established basic airway clearance treatment in Cystic Fibrosis (CF). However, there is scarce evidence regarding the practical implementation and administration of different HS…
- Trial name
- NCT01943890
- Testing
- Hypertonic saline, Physiotherapy
- Where
- Norway
- Volunteers
- 8 people
- Sponsor
- Haukeland University Hospital
Respiratory Distress Syndrome
Sustained Lung Inflation in the Delivery Room in Preterm Infants at High Risk of Respiratory Distress Syndrome
BACKGROUND. Sustained lung inflation (SLI) associated to an adequate PEEP may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical…
- Trial name
- SLIS (NCT01440868)
- Testing
- Sustained lung inflation
- Where
- Italy
- Volunteers
- 276 people
- Sponsor
- University of Florence
Cerebral Palsy
GO-PLAY - Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy
Background. Early diagnosis of cerebral palsy (CP) is important to enable appropriate intervention at a time when neuroplasticity is at its highest.
- Trial name
- GO-PLAY (NCT05883969)
- Testing
- GO-PLAY, Usual care
- Where
- 2 sites in Denmark
- Volunteers
- 60 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Adrenoleukodystrophy, Metachromatic Leukodystrophy
HSCT for High Risk Inherited Inborn Errors
Hematopoietic stem cell transplantation has proven effective therapy for individuals with adrenoleukodystrophy (ALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD, or Krabbe disease).
- Conditions
- Adrenoleukodystrophy, Metachromatic Leukodystrophy, Globoid Cell Leukodystrophy, Tay Sachs Disease
- Trial name
- NCT00383448
- Testing
- Clofarabine, Total body Irradiation, Melphalan
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Neonatal Respiratory Distress
A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure
The investigators hypothesize that there is a growing trend of the feasibility of HFNC as an alternative to other forms of non-invasive ventilation mechanism to provide continuous distending pressure to preterm infants.
- Trial name
- NCT04051762
- Testing
- High flow nasal cannula vs. Nasal continuous positive airway pressure
- Where
- Egypt
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ramy Saleh Morsy
Respiratory Syncytial Virus (RSV)
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for…
- Trial name
- Synagis Russia (NCT02968173)
- Testing
- Palivizumab
- Volunteers
- 50 people
- Sponsor
- AbbVie
Infants in NICU Ventilated With HFV
Capnography in Infants Ventilated With High Frequency Ventilation
The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent the arterial CO2 (PaCO2).
- Trial name
- NCT00859209
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- Bnai Zion Medical Center
Respiratory Insufficiency
High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
The purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing.
- Trial name
- NCT01531465
- Testing
- Pulmonary Function Testing & esophageal pressure monitoring, Pulmonary function testing and esophageal pressure
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Respirtory Distress
Study of the Effects of CPAP and HHHFNC on Diaphragmatic Dimensions in Preterm Infants
This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion…
- Trial name
- NCT02421328
- Testing
- CPAP first (Fisher & Paykel Healthcare), HHHFNC first (Fisher & Paykel Healthcare)
- Where
- 2 sites in Egypt
- Volunteers
- 24 people
- Sponsor
- Mansoura University Children Hospital
Cerebral Palsy, Infant Development
Associations Between General Movements Assessments and Cognitive Development
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant Development, Cognitive Dysfunction, Cognitive Developmental Delay
- Trial name
- GMs (NCT05217056)
- Testing
- measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Neonatal SEPSIS
NeoAMR Observational Study in Neonatal Sepsis
Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess…
- Trial name
- NCT03721302
- Testing
- Main study clinical sepsis, Microbiology sub study
- Where
- 19 sites in Bangladesh, Brazil and 9 more
- Volunteers
- 3,202 people
- Sponsor
- Drugs for Neglected Diseases