Clinical trials: Very Preterm Birth
Hearing Loss, Mental Retardation
Postnatal HCMV Infection in Very Preterm Infants. Implications, Morbidity, Growth and Neurodevelopmental Outcomes.
The aim of this study is to investigate short and long term consequences from early postnatal HCMV infection transmitted via human milk in very preterm infants (birth weight < 1500 g or gestational age < 32 weeks).
- Conditions
- Hearing Loss, Mental Retardation, Microcephaly, Chorioretinitis
- Trial name
- NCT01151462
- Where
- Norway
- Sponsor
- Oslo University Hospital
Very Low Birthweight
Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment.
- Trial name
- NCT01385254
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Duke University
Preterm Infant, Birth, Preterm
Aeration, Breathing, Clamping Study 3
Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages.
- Trial name
- ABC3 (NCT03808051)
- Testing
- Physiological-based cord clamping, Time-based cord clamping
- Where
- 10 sites in Netherlands
- Volunteers
- 689 people
- Sponsor
- Leiden University Medical Center
Preterm, Birth Weight
Impact of Modified Feeding Protocol on Neonatal Outcomes
The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg.
- Conditions
- Preterm, Birth Weight, Feeding Disorder Neonatal
- Trial name
- NCT06246032
- Testing
- Modified feeding Protocol
- Where
- Saudi Arabia
- Volunteers
- 30 people
- Sponsor
- Imam Abdulrahman Bin Faisal University
RDS - Infants, RDS of Prematurity
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance…
- Conditions
- RDS - Infants, RDS of Prematurity, Respiratory Failure, Prematurity
- Trial name
- NCT04542096
- Testing
- Lung electrical impedance tomography monitoring
- Where
- Lithuania
- Volunteers
- 72 people
- Sponsor
- Vilnius University
Respiratory Distress Syndrome
Minimally Invasive Surfactant Therapy Followed by CPAP (MISTCPAP) in Preterm Infants With RDS
There is a reducing incidence of pneumothorax, PIE and the combined outcome of death or BPD since the development of Surfactant therapy.
- Trial name
- MISTCPAP (NCT01723683)
- Testing
- Surfactant
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- China Medical University Hospital
Infant,Premature, Body Weight
Serial Assessment of Body Fat Accrual in Very Preterm Infants
Despite evidence that both rapid weight gain and excessive body fat accrual are associated with overweight and obesity, usual neonatal care of preterm infants does not include assessment of body fat accrual.
- Conditions
- Infant,Premature, Body Weight, Adiposity
- Trial name
- NCT03575897
- Testing
- Assessment of infant body composition
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Alabama at Birmingham
Infant, Very Low Birth Weight
Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants
The purpose of this study is to explore the effects of Oropharyngeal administration of colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the protect immune function of colostrum to very low…
- Trial name
- NCT02389478
- Testing
- Oropharyngeal administration of colostrums, Oropharyngeal administration of Normal saline
- Volunteers
- 64 people
- Sponsor
- Children's Hospital of Fudan University
Premature Birth
Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease
Neurocognitive sequelae observed in preterm represent a major health problem for which there is no preventive treatment approved to date.
- Trial name
- PREMELIP (NCT02395783)
- Testing
- Melatonin 10 µg, Melatonin 20 µg
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Infant, Very Low Birth Weight, Calcium Deficiency
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.
- Conditions
- Infant, Very Low Birth Weight, Calcium Deficiency, Vitamin D Deficiency
- Trial name
- NCT01363167
- Testing
- 400 IU Cholecalciferol- Vitamin D Daily
- Where
- 2 sites in United States
- Volunteers
- 68 people
- Sponsor
- Medical University of South Carolina
Prematurity; Extreme
High Flow Nasal Cannula in Preterm Infants
The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.
- Trial name
- HIFLO (NCT03007056)
- Testing
- High flow nasal cannula
- Where
- France
- Volunteers
- 207 people
- Sponsor
- Hôpital de la Croix-Rousse
Preterm Birth, Premature Lungs
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to…
- Conditions
- Preterm Birth, Premature Lungs, Respiratory Distress Syndrome in Premature Infant
- Trial name
- NCT06295484
- Testing
- Alternating traditional CPAP, NIPPV, and high CPAP
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Sunnybrook Health Sciences Centre
Bronchopulmonary Dysplasia
Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia
The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation.
- Trial name
- REACT (NCT05986032)
- Testing
- Respiratory Oscillometry
- Where
- 6 sites in Austria, Italy and 3 more
- Volunteers
- 150 people
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
Infant, Premature, Diseases
Novel Human Milk Based Human Milk Fortifier
The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).
- Trial name
- MHMHMF (NCT04478487)
- Testing
- Medolac human milk based human milk fortifier (MHMHMF)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Northwest Health
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born…
- Trial name
- NCT07045844
- Testing
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification
- Where
- 24 sites in China
- Volunteers
- 2,324 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Premature Birth
Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment.
- Trial name
- PREMOLF (NCT04906577)
- Testing
- photography+odour, photography
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Babies Born Very Preterm
In-line Filtration to Reduce Systemic Inflammatory Response Syndrome in Babies Born Very prEtErm
While venous access is an essential part of caring for the preterm neonate potential severe adverse events, including contamination of fluids with bacteria, endotoxins and particulates could occur (Bethune 2001).
- Trial name
- FRISBEE (NCT02686060)
- Testing
- 0.2 micron positively charged PALL Corporation filters and 1.2 micro IV in-line filters used for lipid administration
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Morbidity;Newborn, Morality
Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement
A multicenter interventional study using evidence-based collaborative quality improvement to reduce mortality and major morbidities of very preterm infants in six neonatal centers in Shanghai
- Trial name
- NCT04531839
- Testing
- Evidence-based collaborative quality improvement
- Where
- 6 sites in China
- Sponsor
- Children's Hospital of Fudan University
Prematurity
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth.
- Trial name
- NCT01487928
- Testing
- Human Milk Cream
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Baylor College of Medicine