Phase 2 N=87 Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
Infantile Colic
Primary: Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline — 6; 39 Participants — p=<0.0001
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=80 Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic
Infantile Colic · Colic, Infantile
Primary: Number of Participants With >=50% Reduction in Mean Weekly Crying Duration — 32; 13; 3; 24 Participants — p=0.0001
Phase 2 N=90 Effects of Acupuncture in the Treatment of Infant Colic
Infant Colic
Primary: Change in Crying Time Per 24 Hour Period. — 220; 212; 230; 186 minutes crying time pr 24 hour
Phase 4 N=180 Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics
Infantile Colics
Primary: Median Daily Crying Time at the End of the Treatment — 50; 55; 80 minutes
N/A N=30 Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic
Colic · Inflammation
Primary: Daily Average Crying and Fussing Duration According to Barr Diary Records — 111; 133 minutes
Phase 2 N=115 Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
Infantile Colic
Primary: Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. — 284.57; 273.6; 283.91; 185.8 Minutes
Phase 4 N=20 INF108F in Infants With Food Protein Induced Proctocolitis
Infant Development · Gut Microbiome · Food Protein Induced Allergic Proctocolitis
Primary: Changes to Gut Microbiome Composition — 42.816; -12.413 Change in %B.infantis reads (Day 28-BL) — p=0.154
N/A N=51 An Intervention to Decrease Infant Crying
Colic
Primary: Hours Per Day of Fuss/Cry — 2.20; 1.48 hours per day
N/A N=76 Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
Gastroesophageal Reflux Disease
Primary: CLINICAL OUTCOME OF FEEDING SUCCESS — 33; 44 percentage of participants — p=0.28
N/A N=24 Probiotics in Infants With Gastroschisis
Gastroschisis
Primary: Composition of the Fecal Microbiota — 42; 12; 1.1; 14 percentage of total bacteria — p=<0.01
Phase 2 N=27 Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
Colic
Primary: The Absolute Differences of I-GERQ-R Total Score at V3 (End of First Week of Treatment) Respect to the Baseline (V2). — -6.8; -7.6; -6.8 score on a scale
Phase 3 N=18 Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
Gastroesophageal Reflux
Primary: Bradycardia Episodes/Day — 4.6; 3.6 episodes per day
N/A N=94 Lcr35 for Children With Functional Constipation
Constipation
Primary: Number of Participants With Treatment Success (≥3 Spontaneous Defecations Per Week With no Fecal Soiling — 24; 28 Participants — p=0.399
Phase 4 N=96 Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants
Meconium Ileus · Very Low Birth Weight Infant
Primary: Time to Complete Meconium Evacuation in Days — 7; 8 days of life — p=0.61
N/A N=33 A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants
Clubfoot
Primary: NIPS (Neonatal Infant Pain Scale) — 2.28; 1.63; 1.84; 0.91 units on a scale
N/A N=22 Cold Milk for Dysphagia in Preterm Infants
Dysphagia of Newborn
Primary: Percentage of Infants With Improvement of Dysphagia — 58 Percentage of patients
Phase 2 N=18 Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies
Prematurity · Intestine Perforation · Necrotizing Enterocolitis (NEC)
Primary: The Serum Biomarkers of Inflammatory Cytokines
N/A N=31 Efficacy of Open Label Placebo in Children With FGIDs
Functional Abdominal Pain · Functional Dyspepsia · Irritable Bowel Syndrome
Primary: The Primary Outcome Measure Was Mean Daily Pain — 39.9; 45.14 pain scale by VAS in mm — p=<0.03
N/A N=90 Effects of Probiotic and Prebiotic Combinations on Premature Infants
Premature Infants · Stool Bacterial Composition · Growth
Primary: Weight Gain — 618; 590; 682 Grams — p=>0.5
Phase 3 N=81 Anxiety and Recurrent Abdominal Pain in Children
Abdominal Pain · Anxiety
Primary: Clinical Global Impression Scale - Improvement (CGI-I) Will be Used to Assess Overall Global Illness Improvement. CGI-I Scores of 1 (Very Much Improved) or 2 (Much…
N/A N=54 Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression
Postpartum Depression
Primary: Hamilton Rating Scales of Depression — 12.09; 17.17 units on a scale — p=.01
Phase 1 N=12 Effect of Medium Chain Triglyceride Intake on Colonization of Preterm Infants With Candida
Candida Infection · Premature Infant
Primary: Stool Fungal Burden — 500; 55000; 1671; 622.5 cfu per gram — p=0.9
N/A N=109 Mechanisms and Management of Infant Dysphagia
Dysphagia · Airway Aspiration · Airway Penetration
Primary: Number of Participants With Successful Safe Oral Feeding — 51; 31 Participants — p=0.008
Phase 2 N=56 Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
Complication Due to Immunization
Primary: The Change in the Number of CRE (Extracted From Printed Monitoring Tracings Compared to Noted Nurses' Surveillance) Following the First Dose of Pentavalent Vaccine in…
Phase 2 N=19 A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
Functional Constipation
Primary: Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period — 3.181; 2.503; 0.246; 3.371 SBMs/Week
Phase 2 N=48 Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Extremely Low Gestational Age Newborn · Premature Infant
Primary: Urinary Secretary IgA Concentration at 2 Weeks of Age — 233.8; 48.3 ng per g creatinine — p=0.006
N/A N=134 Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates
Infant, Newborn · Infant, Premature · Pain Perception
Primary: Change in Nociception-specific Brain Activity — 17.9; 9.9; 11.5; 10.2 microvolts*milliseconds — p=<0.001
N/A N=22 Effect of Inulin-type Fructans on Constipated Children.
Constipation
Primary: Stool Consistency — 2.57; 1.63 units on a scale
N/A N=100 A Clinical Trial of A Pacifier-Activated Music Player
Prematurity
Primary: Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5) — 2.0; 0.9 mL/min
N/A N=79 Glycerin Suppositories to Reduce Jaundice in Premature Infants
Idiopathic Hyperbilirubinemia · Neonatal Hyperbilirubinemia · Prematurity
Primary: Total Number of Hours of Required Phototherapy — 72; 61 hours