Treatment Trials

14 Clinical Trials for Various Conditions

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COMPLETED
Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)
Description

The overall purpose of this investigation is to better understand factors contributing to the high incidence of prone sleep positioning in African-American infants. In addition, the investigators are interested in investigating other races and ethinicities to understand their beliefs and perceptions and determine differences socioeconomically and socioculturally within and between groups. The investigators will address the following specific aims: (-) To compare knowledge, attitudes, and practices regarding infant sleep position in parents of higher and lower SES. (-) To identify risk factors for non-use of recommended supine sleep position in families with higher and lower SES (-) to develop a phenomenologic understanding of the decisions made by parents of higher SES and lower SES who do nt use recommended supine sleep position, using qualitative techniques.

RECRUITING
Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record
Description

The study team will evaluate the impact of an Infant Sleep Assessment (ISA) tool with motivational interviewing (MI) communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent reported and observed infant sleep practices. The study team's hypotheses are that 1) clinicians who utilize the ISA with MI training will more effectively communicate safe sleep information to their patients' parents, and 2) these parents will have safer infant sleep practices than parents whose clinicians are in a standard of care control group.

COMPLETED
Infant Care Practices Study
Description

This proposed project will engage American Indian communities through existing partnerships, utilizing a Community Based Participatory Research (CBPR) methodology to design a group intervention program to increase the safety of infant sleep environments. Compelling evidence from research in other racial populations suggests that family and cultural norms, attitudes and personal beliefs about infant sleep, safety and comfort are strongly associated with the choice of infant sleep environment. It may be possible that the current safe sleep messages are in conflict with inherent cultural beliefs within these communities. This conflict with the scientific recommendations regarding safe sleep may influence behavior, even in the presence of adequate knowledge about safe sleep practices. Preliminary discussions with many tribal leaders and elders suggest that this chasm between culture and scientific recommendations can be bridged with an intervention incorporating culture, education and resources. However, there is limited research on factors influencing infant safe sleep practices of American Indian mothers. This study will test the effectiveness of incorporating cultural beliefs and practices into an intervention package based on the American Academy of Pediatrics safe sleep guidelines that incorporates both education and provision of resources. Therefore, the research question is: "Does a culturally specific safe sleep intervention, developed using CBPR, reduce the risk of unsafe infant sleep practices in Northern Plains American Indian communities?"

UNKNOWN
Generations in Families Talking Safe Sleep
Description

Teen mothers present a unique set of challenges in reducing the risk for sleep-related infant mortality, in part because they may not be the sole decision-maker for an infant's sleep environment and position and they make seek advice from older female support people. Investigators will conduct a randomized controlled trial of a educational intervention to mitigate the risks of unsafe infant sleep practices across generations. Given the complexity and variability of teen-SCG relationships, investigators will include an examination of inter- and intra-personal factors that are key control variables or may mediate the uptake of safe sleep recommendations. Investigators believe that the intervention will empower support people to positively influence a teen mother's adoption of safe sleep recommendations.

COMPLETED
Enhancing Safe Sleep Practices of Urban Low-Income Mothers
Description

The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician anticipatory guidance about safe sleep and identify physician, patient and parent characteristics associated with coverage of the topic at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies (BHB)'s safe sleep campaign messages and services among our study participants.

COMPLETED
Comparing Children's Book to Brochures for Safe Sleep Education in a Home Visiting Program
Description

This randomized controlled trial compares a specially-designed children's book to standard brochures for safe sleep education and reduction of Sudden Infant Death Syndrome (SIDS) risk in a high-risk population of young, first-time mothers enrolled in a home visitation program. Roughly half of the mothers will receive safe sleep education via the book, the other half via brochures, during prescribed home visits. Our study will assess differences in safe sleep knowledge, adherence to recommendations, satisfaction with materials used, and attitudes towards reading with their baby. Our hypothesis is that these will be higher in the group receiving the book, due to simpler language, appealing illustrations, emotional connection, and repeated exposures via shared reading.

COMPLETED
Changes in Sleep Patterns and Stress in Infants Entering Child Care
Description

When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.

RECRUITING
Support Via Online Social Networks to Promote Safe Infant Care Practices
Description

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents.

RECRUITING
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Description

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.

COMPLETED
Study of the Impact of Parental Note Taking on the Effectiveness of Anticipatory Guidance
Description

The delivery of anticipatory guidance is an essential component of pediatric practice. Given the large amount of information to be shared during each encounter and the limited time available, there is a need for an effective and efficient means of communication between health care providers and families. The investigators hypothesize that more active parental participation in the form of note taking during the delivery of anticipatory guidance will lead to increased knowledge, higher levels of satisfaction with the encounter, and increased adoption of recommended parenting practices. In this study, the investigators propose a randomized controlled trial of the impact of note taking during the delivery of newborn anticipatory guidance on maternal practices related to newborn care. The investigators plan to compare a control group of mothers receiving standard of care anticipatory guidance with an intervention group of mothers who are encouraged to take written notes while receiving the anticipatory guidance. The primary outcome of interest is maternal practice related to infant sleep position, and the secondary outcomes of interest are maternal practice related to breastfeeding initiation and car seat use. The investigators also plan to evaluate the impact of note taking on mothers' knowledge of recommended practices related to newborn care and on mothers' satisfaction with the guidance received.

COMPLETED
Re-enforcing Safe Sleep Practices for Caregivers With Tangible Incentives
Description

This study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.

COMPLETED
Reduce African-American Infant Mortality
Description

The overall purpose of this randomized trial is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment. African-American parents of newborn, healthy term infants will be randomized to receive either a standard message to avoid bedsharing, eliminate use of soft bedding and soft sleep surfaces, and to place infants in the supine position for sleep to reduce the risk of SIDS or an enhanced message to avoid these behaviors to both reduce the risk of SIDS and to prevent infant suffocation.

Conditions
COMPLETED
Comparing Children's Books to Brochures for Safe Sleep and Infant Reading Education During Prenatal Care
Description

The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit. Mothers in the control group will receive a specially designed children's book regarding the importance of reading with their infant at this visit, compared to brochures. Knowledge of safe sleep and home literacy orientation will be assessed at baseline prenatally, and their first postpartum obstetric visit.

COMPLETED
Training Mothers of Infants in Infant Cardiopulmonary Resuscitation (CPR)
Description

This research will be a prospective, cohort study to determine if mothers of infants/newborns are more willing to complete CPR training using a 22-minute instructional DVD and infant manikin versus traditional four hour didactic instruction. Study Hypothesis: A 22-minute instructional DVD and infant manikin will be an effective and preferred tool for teaching mothers of infants infant CPR. Objectives 1. To determine if mothers of infants are more likely to complete infant CPR training with a 22-minute instructional DVD and infant manikin, than by attending a traditional CPR class. 2. To determine if learning infant CPR with a 22-minute instructional DVD and infant manikin is as effective as attending traditional infant CPR class. 3. To examine the number of mothers that were offered the opportunity to learn infant CPR either as part of their prenatal classes, or upon the birth of their infant. 4. To examine the number of mothers who have been previously trained in CPR. 5. To examine the reasons that mothers have been previously trained in CPR (e.g., mandated by work/career vs. personal reasons). 6. To examine the multiplier effect of an at home CPR education using a 22-minute instructional DVD and infant manikin at the time of the follow up phone call.