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Crying clinical trials

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NCT ID: NCT04608877 Completed - Clinical trials for Parent-Child Relations

Take 5 + Audio Clip Randomized Control Trial

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

At Yale New Haven Hospital, parents on the postpartum ward receive a Take 5 program to help train and prepare parents for strategies to manage their infant's crying. Inconsolable crying is a leading cause for abusive head trauma (AHT) in infants, and the Take 5 program has proven effective in reducing rates of AHT. However, it is also important to examine new ways of improving AHT preventative programs to optimize outcomes for infants. The purpose of this proposal is to determine whether adding a one-minute audio-clip of an infant crying, which specifically addresses AHT, to the Take 5 message given to parents of newborns on the postpartum floor of the hospital strengthens the preventive message. This is a randomized controlled trial (RCT) of parents on the postpartum ward; half will receive just Take 5, and the other half will receive the audio-clip and Take 5. Our hypotheses to be tested are that relative to parents who had Take 5 alone, those parents who hear the audio-clip before learning Take 5 will: 1. Have higher HR/BPs and higher negative affect after the training session 2. Be more likely to remember use Take 5 when they became frustrated with their infant's crying when followed up 6 weeks later. 3. Be more likely to tell other people about Take 5 and be more likely to say Take 5 was useful.

NCT ID: NCT04374955 Completed - Clinical trials for Microbial Colonization

The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

This study aims to investigate the effect of probiotic added to the diet of mothers on infantile colic in the postpartum period and the content of the neonatal intestinal microbiota.

NCT ID: NCT03390348 Completed - Crying Clinical Trials

An In-home Observational Study to Compare Infant Crying and Fussing Parameters Documented by the LENA Recorder With Those Documented Via Parental E-diaries

LENUS
Start date: November 22, 2017
Phase:
Study type: Observational

This is a in-home observational study of 12 healthy term infants of ≤15 weeks of age to compare infant crying and fussing parameters documented by the LENA recorder with those documented via parental e-diaries

NCT ID: NCT02227979 Completed - Trauma Clinical Trials

Effects of PURPLE Cry Intervention

Start date: September 2013
Phase: N/A
Study type: Interventional

The proposed study is designed to investigate whether the PURPLE Crying program attains efficacy by optimizing the neural response in the anterior insula, and augmenting activity in regions of the brain known to be important for emotion regulation. The aim is to determine the effects of the PURPLE Cry Intervention by investigating the following: - independent variables that may affect a father's neural response to infant cries - effects of the PURPLE cry intervention, compared to a control intervention, on fathers' reported aversiveness and empathy in response to cry stimuli - effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural response to unknown infant cries compared to a tone control - effects of the PURPLE cry intervention, compared to a control intervention, on fathers' neural responses to own infant cries compared to unknown infant cries The investigators hypothesize: - prior to the PURPLE material, fathers' neural responses to infant cry stimuli will be modulated by the following variables: subjective self-reported emotional reaction to cry stimuli, hormone levels, sleep quality and quantity, sex of the infant, infant temperament, life stressors, parental expectations, personality (neuroticism), and father's own childhood experience - fathers who receive the PURPLE material compared to those that receive the control intervention will report a larger decrease in aversiveness and a larger increase in empathy in response to cry stimuli - fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger decrease in activity in the anterior insula and amygdala in response to cry stimuli - fathers who receive the PURPLE material compared to those that receive the control intervention will show a larger increase in activity in regions of the brain important for emotion regulation, such as the dorsolateral prefrontal cortex (PFC) and orbitofrontal PFC - fathers' neural activity in the amygdala in response to their own infant's cry stimuli will be positively correlated with both their own and infant testosterone levels

NCT ID: NCT01855269 Completed - Crying Clinical Trials

Lactobacillus Reuteri Versus Herbal Drop in the Treatment of Infantile Colic: a Prospective Study

Start date: April 2012
Phase: N/A
Study type: Interventional

The aim was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospective randomized controlled study would improve symptoms of infantile colic.

NCT ID: NCT01513226 Completed - Sleep Clinical Trials

Cycled Light and Crying of Preterm Infants

Start date: June 2006
Phase: N/A
Study type: Interventional

This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.

NCT ID: NCT01046617 Completed - Infantile Colic Clinical Trials

Lactobacillus Reuteri for the Treatment of Infantile Colic:

LRTIC
Start date: December 2009
Phase: Phase 3
Study type: Interventional

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. The crying typically starts in the first few weeks of life and ends by 4-5 months of age. The condition is usually self-limited, with no long-term adverse effects; however, it may be very distressing to parents, hence, any safe and effective treatment would be desirable. Recently, it has been suggested that probiotics may offer some benefit.This is based on the results of one open randomized controlled trial. In this trial, 83 breast-fed infants with colic defined as >3 hours of crying on >3 days/week were randomly allocated to receive Lactobacillus reuteri DSM 17938 (108 colony-forming units, once daily 30 minutes after feeding) or simethicone (60 mg/day as 15 drops twice a day after feeding) for 28 days. Mothers followed a cow's milk free diet. By day 28 after randomization, mothers of infants in the probiotic group were significantly more likely than mothers of infants in the simethicone group to report a reduction from baseline in average crying time to less than 3 hours per day (95% vs. 7%). In addition, median crying times were significantly shorter in the probiotic group than in the simethicone group. No adverse effects of L. reuteri were reported. Although the mechanism of action of L. reuteri for treating infantile colic has not been elucidated yet, the findings are very promising. However, there are some methodological limitations to the study, including no allocation concealment, no blinding, and no intention-to-treat analysis; these may result in selection, performance, and/or attrition biases and, eventually, invalidate the results. Another limitation of the study is the lack of a true placebo group. Given these consideration a new study is proposed that is aiming to overcome these limitations.