Clinical trials: Preterm Infants
Necrotizing Enterocolitis
Probiotics in the Management of Necrotizing Enterocolitis in HIV-exposed Premature Infants
A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period July 2011 to August 2012.
- Trial name
- NCT01868737
- Testing
- Probiotic
- Where
- South Africa
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch
Amount of Breast Milk, Maternal Anxiety Level
The Effect of Music on Maternal Stress and Milk Amount
Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units.
- Trial name
- NCT06307756
- Testing
- Music group
- Where
- Turkey (Türkiye)
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Adiyaman University
Respiratory Distress, Hypoglycemia
Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year
Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term).
- Conditions
- Respiratory Distress, Hypoglycemia, Feeding Intolerance, Jaundice
- Trial name
- NCT00550069
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sheba Medical Center
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Mother-Infant Interaction, Premature Birth
The Effect Of Baby Smell On The Amount Of Breast Milk, Salivary Cortisol Level And Mother Baby Attachment
The goal of this [type of study: randomized controlled clinical trial] is to [determine the effect of applying the scent of premature newborns who cannot be breastfed to the mother on the mother's milk amount, salivary cortisol…
- Trial name
- NCT06096961
- Testing
- Baby smell
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eskisehir Osmangazi University
Premature Infant, Clustered Care
Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
The Individualized Developmental Care (IDC) model was developed to minimize the negative impact of the neonatal intensive care environment and to support infants' physiological stability.
- Conditions
- Premature Infant, Clustered Care, Neonatal Intensive Care Unit, Developmental Care
- Trial name
- Guideline (NCT07052786)
- Testing
- Infants will receive group care based on individualized developmental care according to the guide., Standard care
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- KTO Karatay University
Wheezing
A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants
The primary objective of this study is to assess the efficacy of motavizumab compared to placebo when administered monthly to preterm infants during their first RSV season for the reduction of the incidence of serious early…
- Trial name
- NCT00628303
- Testing
- Motavizumab
- Volunteers
- healthy volunteers welcome
- Sponsor
- MedImmune LLC
Respiratory Syncytial Virus Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and…
- Trial name
- MELODY (NCT03979313)
- Testing
- MEDI8897
- Where
- 198 sites in United States, Argentina and 29 more
- Volunteers
- 3,012 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Other Preterm Infants
Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.
While using the device as a cushion, the passive distribution of pressure over bony skull prominences of infants will protect against formation of pressure ulcers.
- Trial name
- INV-CS-001 (NCT02224859)
- Testing
- HCP will place the Invictus Cranial Support Device (CSD) on the patient, human intervention
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Invictus Medical, Inc.
Other Preterm Infants, Vitamin D Deficiency
The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity
This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants.
- Conditions
- Other Preterm Infants, Vitamin D Deficiency, Bronchiolitis, Asthma
- Trial name
- NCT02404623
- Testing
- Vitamin D
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Soroka University Medical Center
Breast Milk Collection, Breast Pumping
Breast Massage and Hot Compress Application to Mothers With Premature Babies at Newborn Intensive Care University Effect on Milk Release and Anxiety
This research was carried out in order to determine the effect of breast massage and hot compresses on milk release and anxiety to mothers with premature babies in YYBU (Neonatal Intensive Care Unit)
- Conditions
- Breast Milk Collection, Breast Pumping, Massage Therapy
- Trial name
- NCT05420389
- Testing
- breast massage, hot compress, breast massage-hot compress
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Seyma Ertugral
Face, Newborn
Fitting of Commonly Available Face Masks for Late Preterm and Term Infants
Around ten percent of newborn infants require positive pressure ventilation (PPV) in the delivery room. This is most commonly delivered using a round or anatomically shaped face mask attached to a T-piece device, self-inflating…
- Conditions
- Face, Newborn, Preterm Infant
- Trial name
- CAFF (NCT03369028)
- Testing
- 2D and 3D image of infants´ faces
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
Premature Birth of Newborn
Enteral Feeding and Early Gut Colonization of Preterm Infants
The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the…
- Trial name
- PRECOL (NCT02502916)
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Universidad Complutense de Madrid
Thermometry
Comparison of Three Methods of Taking Temperatures in the Newborn Intensive Care Unit
Preterm infants will have their body temperature measured by three different devices in order to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate for patients in the preterm period.
- Trial name
- NCT01012128
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Retinopathy of Prematurity
Heredity of Retinal Vessel Tortuosity
The purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged 20-46 years.
- Trial name
- NCT00427063
- Where
- Denmark
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Glostrup University Hospital, Copenhagen
Newborn; Vitality, Nursing Caries
Effect of Intranasal Breast Milk Administration in Preterm Infants
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
- Conditions
- Newborn; Vitality, Nursing Caries, Breast Feeding
- Trial name
- NCT06706115
- Testing
- Intranasal human breast milk
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Transient Tachypnea of the Newborn, Neonatal Respiratory Distress
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn.
- Trial name
- NCT04780412
- Testing
- Misoprostol
- Where
- Egypt
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Stress, Sleep
Music's Effects on Premature Babies.
This project is being done in order to determine if the music of Mozart will have a soothing effect on premature infants while in the neonatal intensive care unit (NICU).
- Trial name
- NCT00224211
- Testing
- Music
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Sensation Disorders
Relationship Between Sensory Processing and Motor Development
The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants.
- Trial name
- NCT02889887
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Gazi University
Necrotizing Enterocolitis (NEC), Healthy Control
Predictive Diagnosis of Ulcero-Necrotizing EnteroColitis in Premature Babies Using an Artificial Intelligence Approach Based on Early Analysis of the Fecal Microbiota
Prematurity affects around 7% of births in France. Necrotizing enterocolitis (NEC) is a dreaded digestive complication. It is responsible for a mortality rate ranging from 15 to 40%, a rate that has remained stable in recent…
- Trial name
- PECUNIA (NCT06727877)
- Testing
- Ability of early digestive microbiota analysis (using artificial intelligence) to predict the occurrence of NEC diagnosed according to the Bell classification.
- Where
- 5 sites in France
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- University Hospital, Clermont-Ferrand