Clinical trials: Infant, Premature Development
Neurophysiologic Maturation
Neurophysiologic Maturation Index for Late Preterm Infants
Late preterm infants contribute to significant neonatal intensive care unit health care resource utilization because of their sheer numbers. Determinants of the length of hospitalization (LOH) in this population are understudied.
- Trial name
- NEMO Project (NCT02156817)
- Testing
- Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition
- Where
- 3 sites in United States, Canada
- Volunteers
- 26 people
- Sponsor
- Brown University
Postnatal Growth Disorder
Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured?
It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth.
- Trial name
- TFO2 (NCT02865941)
- Testing
- Fortification with modular protein, Fortification with modular carbohydrate, Fortification with modular fat
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- McMaster Children's Hospital
Infant Development, Protein-energy; Imbalance
Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Macronutrient Composition to Improve Growth
The purpose of this study is to measure protein turnover rates in preterm infants.
- Conditions
- Infant Development, Protein-energy; Imbalance, Protein Deposition
- Trial name
- NCT04854226
- Testing
- Macronutrients_CARB, Macronutrient_FAT
- Where
- 3 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Paracelsus Medical University
Infant Development, Premature
Hammock Position and Kangaroo Care
This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants.
- Trial name
- NCT06436404
- Testing
- Hammock intervention, Kangaroo care intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Nigde Omer Halisdemir University
Postnatal Growth Disorder
Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study
To analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.
- Trial name
- IFO Pilot (NCT01305642)
- Testing
- Individualized fortification of breast milk
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- McMaster Children's Hospital
Autism, Prematurity
Eye Tracking and Autism in Former Preterm Infants
This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP).
- Trial name
- NCT07764822
- Testing
- Eye-tracking device
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Indiana University
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
Premature Infant
Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the…
- Trial name
- NCT05410639
- Testing
- online education program, no online education program
- Where
- Turkey (Türkiye)
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Marmara University
Hyperbilirubinemia, Neonatal
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB…
- Trial name
- NCT01763632
- Testing
- Transcutaneous bilirubinometry
- Where
- 16 sites in China
- Volunteers
- 19,601 people, healthy volunteers welcome
- Sponsor
- Nanjing Medical University
Infant Sleep Problems, Circadian Rhythm
Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
This study investigates whether the timing of feeding expressed breast milk influences infant sleep and circadian (day-night) development in preterm infants.
- Conditions
- Infant Sleep Problems, Circadian Rhythm, Neurodevelopment
- Trial name
- NCT07533578
- Testing
- Chronobiologically Timed Feeding of Expressed Breast Milk, Usual Feeding Practice (Untimed Expressed Breast Milk)
- Where
- Switzerland
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Luzerner Kantonsspital
Infant, Newborn, Infant, Low Birth Weight
Development of Standards for the New Ballard Maturation Score
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Ballard (NCT01203449)
- Where
- 11 sites in United States
- Volunteers
- 1,090 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
Vitamin A Deficiency, Vitamin D Deficiency
Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance.
- Conditions
- Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency, Very Low Birth Weight Infants
- Trial name
- NCT03876704
- Testing
- High dose of fat-Soluble Vitamin, Conventional dose of fat-Soluble Vitamin
- Where
- China
- Volunteers
- 120 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Preterm Birth, Postpartum Depression
COntact RElationship in Neonatal Intensive Care Unit
The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the…
- Trial name
- CORE in NICU (NCT06462638)
- Testing
- Neurobehavioral states and physiological parameters evaluation, Maternal vocal pitch evaluation to assess depressive/anxious state
- Where
- Italy
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
Infant, Low Birth Weight
Post Discharge Human Milk Fortifier in Preterm Infants
The purpose of this study is to determine whether low birth weight (LBW) infants fed human milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks after hospital discharge will have better…
- Trial name
- NCT00413985
- Testing
- Nutrient-enriched human milk
- Where
- 9 sites in Canada
- Volunteers
- 40 people
- Sponsor
- The Hospital for Sick Children
Bronchopulmonary Dysplasia
The Role of Volatile Organic Compounds (VOCs), Airway Mucins and the Microbiome in the Early Prediction of Bronchopulmonary Dysplasia (BPD)
Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.
- Trial name
- INFANCY (NCT06342752)
- Testing
- Breath test, Throat swabs, Placental samples
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University Hospital, Antwerp
Other Preterm Infants
Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)
Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic input (apport) supposed to allow optimal…
- Trial name
- EPIPOD (NCT01450436)
- Testing
- Peapod assessment
- Where
- France
- Volunteers
- 270 people
- Sponsor
- Nantes University Hospital
Apnea of Prematurity
Caffeine for Apnea of Prematurity (CAP)
At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities.
- Trial name
- NCT00182312
- Testing
- Caffeine citrate injection
- Where
- 34 sites in United States, Australia and 7 more
- Volunteers
- 2,000 people
- Sponsor
- McMaster University
Infant, Premature
Development of Maternal Voice Recognition in Preterm Neonates
Many cognitive functions in humans are based on asymmetrical brain networks. For example, in most adults, the language is essentially processed by the left hemisphere, while other auditory functions, such as voice recognition…
- Trial name
- PREMAVOIX (NCT02818595)
- Testing
- electroencephalogram (HR-EEG), Near Infra Red Spectroscopy (NIRS)
- Where
- France
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill
There have been many studies on the use of running training in older children to improve gait development in children with cerebral palsy.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage Neonatal, Bilirubin Encephalopathy
- Trial name
- NCT03534466
- Testing
- Baby treadmill, Conventional physical rehabilitation training
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Children's Hospital of Fudan University