Clinical trials: Infants
Infant Development, Stress
Multisensory Early Oral Administration of Human Milk in Preterm Infants
The aims of this pilot are to determine the feasibility and acceptability of the Multisensory early oral administration of human milk (M-MILK) intervention, recruitment, retention, and obtain data for sample size estimation.
- Trial name
- M-MILK (NCT06230848)
- Testing
- Multisensory Early Oral Administration of Human Milk (M-MILK)
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Loyola University
Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of…
- Conditions
- Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)
- Trial name
- TOP (NCT01702805)
- Testing
- Liberal Cell Transfusion, Restricted red cell transfusion
- Where
- 20 sites in United States
- Volunteers
- 1,824 people
- Sponsor
- NICHD Neonatal Research Network
Infant Feeding Problems, taVNS
BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement.
- Trial name
- BabyStrong I (NCT04849507)
- Testing
- transcutaneous auricular vagus nerve stimulation
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Medical University of South Carolina
Pregnancy, Infants
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in…
- Conditions
- Pregnancy, Infants, Disparities
- Trial name
- PᵌOPPY (NCT05940688)
- Testing
- Digital Health intervention, Community Health Worker, Digital Health Intervention plus Community Health Worker
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Alabama at Birmingham
Obesity, Infant, Language Development
Music and Child Health and Development
The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old…
- Conditions
- Obesity, Infant, Language Development, Parent-Child Relations
- Trial name
- NCT05868811
- Testing
- Music Together, Play Group
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
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
Parent-Child Relations, Maternal Behavior
A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity
Childhood adversity affects almost two-thirds of the US population, is a major risk factor for the leading causes of disease and increases US economic health burdens.
- Conditions
- Parent-Child Relations, Maternal Behavior, Infant Behavior
- Trial name
- NCT04818112
- Testing
- ATVV, Attention control
- Where
- 2 sites in United States
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- University of Arizona
Respiratory Distress Syndrome in Premature Infant
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.
- Trial name
- NCT03969992
- Testing
- AeroFact, nCPAP
- Where
- 41 sites in United States, Canada
- Volunteers
- 261 people
- Sponsor
- Aerogen Pharma Limited
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
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
Central Line Complication, Neonatal Disease
Impact of Cyanoacrylate Glue on PICC Line Dressing Care
This study will evaluate whether applying micro drops of cyanoacrylate glue to the participant's peripherally inserted central catheter (PICC) insertion site prior to covering the area of PICC line with a transparent film…
- Trial name
- NCT05246709
- Testing
- Cyanoacrylate glue, Standard transparent film dressing
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Columbia University
Infant Development, Hemiplegia
CIMT and taVNS for Hemiplegia in Infants
Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body.
- Conditions
- Infant Development, Hemiplegia, Constraint Induced Movement Therapy
- Trial name
- NCT05101707
- Testing
- transcutaneous auricular vagus nerve stimulation, Constraint induced movement therapy
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Medical University of South Carolina
Cardiovascular Diseases, Infant ALL
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
This pilot study aims to examine the feasibility and acceptability of adding a cardiovascular health module to the existing Nurse Family Partnership (NFP) home visitation program delivered by trained nurses in the Northern…
- Conditions
- Cardiovascular Diseases, Infant ALL, Maternal Behavior, Childhood Obesity
- Trial name
- ENRICH (NCT05824741)
- Testing
- Infant Cardiovascular Health (CVH) Promotion
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Penn State University
Infant Development
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority.
- Trial name
- NCT05106894
- Testing
- smartphone application to promote nurturing care, printed caregiving materials
- Where
- Guatemala
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Los Angeles
Neonatal Abstinence Syndrome
Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes.
- Trial name
- No-POPPY (NCT03396588)
- Testing
- Clonidine, Morphine
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Henrietta Bada
Newborn Infants Having Asystole or Bradycardia at Birth
Chest Compression and Sustained Inflation
Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns.
- Trial name
- NCT02083705
- Testing
- CC+SI, 3:1 CPR
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- University of Alberta
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Gestational Weight Gain, Maternal Fat Accretion
Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion
The purpose of this study is to learn if consuming a high fiber diet will reduce gestational weight gain and maternal and infant fat accretion.
- Conditions
- Gestational Weight Gain, Maternal Fat Accretion, Infant Fat Accretion
- Trial name
- SPROUT (NCT04868110)
- Testing
- High fiber diet
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Very Preterm Maturity of Infant, The Risk Factors for Improving the Prognosis of VLBW Infants
Analyses of Anemia in Very Low Birth Weight (VLBW) Infants.
To study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (VLBW) infants.
- Trial name
- NCT05949788
- Testing
- No intervention
- Where
- China
- Volunteers
- 146 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital