Clinical trials: Crying
Infantile Colic
Cranial Osteopathy in Infantile Colic
Background Excessive Crying (Infantile Colic) is one of the most common complaints for which parents seek treatment. These otherwise healthy and well fed infants show no signs of failure to thrive, cry without identifiable cause…
- Trial name
- NCT01942928
- Testing
- Usual NHS Care, Osteopathic Manipulative Therapy
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- European School of Osteopathy
Infantile Colic
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.
- Trial name
- Coco (NCT01721850)
- Testing
- control formula, intervention formula 1, intervention formula 2
- Where
- 18 sites in Germany, Italy
- Volunteers
- 169 people, healthy volunteers welcome
- Sponsor
- HiPP GmbH & Co. Vertrieb KG
Infantile Colic
Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial (ACU-COL)
The purpose of this prospective randomized three armed, multi center study is to compare the effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile colic.
- Trial name
- ACU-COL (NCT01761331)
- Testing
- Acupuncture
- Where
- 4 sites in Sweden
- Volunteers
- 147 people
- Sponsor
- Lund University
Infants
Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification
Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a…
- Trial name
- LongCRY (NCT03716882)
- Testing
- Song Meter (SM)4
- Where
- France
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Crying
Feeding Intervention for Infants With Crying
The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.
- Trial name
- NCT01017991
- Testing
- Milk based infant formula with probiotic, Milk based infant formula
- Where
- 9 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infantile Colic, Crying
Lactobacillus Reuteri for the Treatment of Infantile Colic:
Infantile colic is characterized by excessive crying (defined as crying that last at least 3 hours a day, for 3 days a week, for at least 3 weeks) in an otherwise healthy infant.
- Trial name
- LRTIC (NCT01046617)
- Testing
- Lactobacillus reuteri (DSM 17938)
- Where
- Poland
- Volunteers
- 80 people
- Sponsor
- Medical University of Warsaw
Excessive Crying, Prolonged Pain
Assessment of Prolonged Pain in Infants With Excessive Crying: Contribution of Infrared Thermal Imaging - The NEOTHERM Pilot Study
NEOTHERM is a multicenter, prospective, observational pilot study examining whether infrared thermal imaging (ITI) can contribute to the assessment of prolonged pain in infants with excessive crying.
- Trial name
- NEOTHERM (NCT07693179)
- Where
- 3 sites in France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier de Saint-Denis
Healthy
A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app.
- Trial name
- COOL (NCT03729960)
- Testing
- LENA recorder
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Infantile Colic, Infant Sleeping Habits
Role of ProTectis on Infant Colic and Its Effect on Infant Crying Time and Maternal Mental Health
This study will work on hypothetical assumption that compared to the arm supplemented with placebo (control) group; the L reuteri (intervention) group will lower daily crying/fussing time per 24 hours at one month post…
- Conditions
- Infantile Colic, Infant Sleeping Habits, Maternal Mental Health.
- Trial name
- PRIC-SMM (NCT02094092)
- Testing
- ProTectis drops (five drops per day) for 21 days
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Ferozsons Laboratories Ltd.
Pain, Infant, Newborn, Disease
Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection
This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.
- Trial name
- NCT05520164
- Testing
- Listening the maternal heart sound during the invasive interventions
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
Neonatal, Pain Management
The Effect of Scents Applied During Heel Blood Collection on Newborn Crying Duration, Pain, and Physiological Parameters
One of the most common and painful procedures in newborns is taking a capillary blood sample from the heel. This basic procedure, widely used in early health assessments, particularly in newborn screening tests, can cause mild to…
- Trial name
- Randomized (NCT07350980)
- Testing
- oil
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Sakarya University
Family-centered Care
The Effect of Maternally Scent-digested Blanket on Stress, Crying and Physiological Parameters of Premature Newborns
Olfaction is a highly developed and crucial sensory modality that connects the infant and the mother, facilitating the infant's ability to locate and reach the mother's breast.
- Trial name
- NCT06437106
- Testing
- A blanket impregnated with the mother's odor, blanket without mother's smell, control group
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Colic
Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants
Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies.
- Trial name
- CRI (NCT02586558)
- Testing
- Experimental Infant formula, Reference group
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- McMaster University
Infant Nutrition
Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics
To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-hydrolyzed formula.
- Trial name
- NCT01036243
- Testing
- test formula 1, test formula 2, test formula 3
- Where
- Thailand
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Gastrointestinal, Colic
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe…
- Trial name
- NCT01849991
- Testing
- Lactobacillus reuteri
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Infantile Colic
Parental Blinding in Clinical Trials of Osteopathy
The aim of this research is to assess the acceptability of using a mobile folding screen for blinding parents of infant study participants in clinical trials of osteopathic interventions.
- Trial name
- NCT02511171
- Testing
- Cranial osteopathic manipulative therapy
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- European School of Osteopathy
Infant Behavior
Validation of Active-Insights Device to Measure Crying Time
To assess the ability of a machine learning algorithm to accurately detect fussing and crying time in infants using accelerometery data collected from a wearable device, compared to the Barr's parent-/caregiver-completed…
- Trial name
- NCT05165589
- Testing
- ActiveInsights accelerometer device
- Where
- Ireland
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- BioGaia AB
Infantile Colic
CHiropractic for Infantile Colic Study
The purpose of this study is to investigate whether a course of chiropractic treatment has a significant impact on the natural course of infantile colic, specifically: 1.
- Trial name
- CHIC (NCT02138656)
- Testing
- Chiropractic, Best Standard Care
- Where
- United Kingdom
- Volunteers
- 1 people
- Sponsor
- University of Southampton
Infantile Colic
Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old
Study type: Randomized controlled trial with two parallel arms Objectives Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula containing L.
- Trial name
- NCT02430831
- Testing
- Nidina
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- University of Bari
Infantile Colic
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.
- Trial name
- NCT07190859
- Testing
- L. reuteri
- Where
- 4 sites in Bulgaria
- Volunteers
- 50 people
- Sponsor
- BioGaia AB