Clinical Research Directory

Effects of Melatonin on Excessive Crying in Neonates. A Randomized Controlled Clinical Trial.

the goal of this clinical trial is to learn if melatonin could reduce the duration of excessive crying and infantile colic in neonates and if this drug can be an option to be used in treating such problem- infantile colic and crying which creates anxiety to the parents, and to assess the safety of using melatonin in neonates. the author invited 165 mothers of 165 neonates having excessive crying more than 3 hours per day over 3 days per week, with ages ranged from 14-20 days with 4 categories of neonates according to the status of delivery: Cesarean section, Difficult labor, premature delivery, Small for gestational Age (IUGR) babies, as well as normal delivery neonates. these neonates will be randomly assigned into group Of melatonin 82 neonates, and 83 neonates will receive oral multivitamins as placebo that was made comparable to melatonin in taste and viscosity and color by the research pharmacy in Mosul, the dose of Melatonin will be 0.1mg/kg/12 hourly ,given daily up to 28 days of the start of administration of both melatonin and multivitamin. randomization is performed using opaque sealed envelopes which are sequentially numbered from 1-178 and allocation is concealed from mothers and the author. the clinic nurse will be the responsible for distribution of allocations. The mother will be instructed to record the daily duration of crying in minutes and report these values by telephone follow up throughout the study. The study design is a double-blinded randomized clinical trial. the whole study is to be conducted in a pediatric clinic prospectively. the group of neonates with melatonin will be compared with the group of neonates receiving multivitamins as placebo in the mean-crying times using t-tests

Recognizing Children's Needs: Impact on Early Childhood Regulatory Problems

Brief Summary: This study aims to quantitatively examine the relationship between regulatory problems (sleep, feeding, and crying) in infants aged 6-36 months and levels of parental sensitivity and reflective functioning. The primary objective is to determine how parents' ability to perceive and interpret their child's cues affects these regulatory difficulties; the secondary objective is to explore how emotional responses to crying and other parent-child interaction factors mediate that relationship. In a cohort of approximately 249 infant-parent dyads, the Revised-Brief Infant Sleep Questionnaire (BISQ-R), feeding and crying assessment forms, the Parental Reflective Functioning Questionnaire, the My Emotions Questionnaire, and the Parental Stress Scale will be administered. Data will be analyzed via descriptive statistics, correlation analyses, and multiple regression models. As the first large-scale quantitative study in Turkey to investigate this area, it will yield unique data to guide parenting programs and early-intervention policies.

Piloting the Attention Training Technique for Post-Stroke Emotionalism

The aim of this mutli-phasic systematic case series is to explore if the Attention Training Technique (ATT) can improve symptoms of Post Stroke Emotionalism. It will teach the ATT to at least three people who have had a stroke at least six months ago, have PSE and are currently receiving support from a Community Neurorehabilitation service in the North West of England. Stroke survivors will also require the support of a carer/loved to record their symptoms on a daily basis. Stroke survivors will attend weekly appointments either at the community service site or via video-call for up to 15 weeks. There is also the option to complete an interview to discuss their experiences of learning the ATT. This study hopes to be the first step in establishing evidence in support of a novel psychological intervention to help improve PSE symptoms. Phase 1 of the study aims to explore the effects associated with the ATT on PSE symptoms. The primary research questions are: 1a. Is the ATT associated with an improvement of PSE symptoms? 1b. Does this replicate across individual cases? If these are not initially supported, the ATT delivery will be extended, addressing: 1. c. Is the ATT associated with an improvement of PSE symptoms when some parameters (e.g., frequency and dose) are modified? Only if a clear association between ATT and symptom change is demonstrated, will Phase 2 begin. Phase 2 aims to understand the relative mechanisms underlying any treatment effect. The primary research question for Phase 2 is: 2. a. Is the ATT associated with a greater change in PSE symptoms than a comparator passive listening intervention (controlling for non-specific factors, (e.g., provision of a credible intervention, task practice and therapist involvement))? The comparator intervention will be a passive version of the ATT whereby participants are instructed to not follow the instructions on the audio-recording. Secondary research questions throughout Phase 1 and 2 will address: 1\. Is the active ATT (and passive ATT) associated with an improvement in executive functioning, attention, mood and quality of life and is there any difference between the two interventions?