Premature Birth Clinical Trials

This is a double blinded, randomized, controlled trial of 2'-Fucosyllactose in infants born between 29 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion. The overall goal of this study is to test daily oral administration of 2'-FL 270 mg/day in the milk of human milk-fed infants who are >1000 gram to <1500 gram birthweight. Read Less

A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age. Read Less

This is a pilot project designed to test the feasibility of implementing a community health worker (CHW)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. The project will be conducted in partnership with the Greater Cleveland Food Bank and the Better Health Partnership Community Health Worker HUB Read Less

The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction. Read Less

The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities. Read Less

The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks. Read Less

Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities. If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance. Read Less

The purpose of this study is to determine whether participation in the Play and Learning Strategies (PALS) parenting intervention results in increased caregiver responsiveness behaviors and to test if participation in PALS results in increases in toddler skills and/or toddler neurological development. Read Less

This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy. Read Less

Antenatal family counseling for anticipated extremely preterm deliveries remains ethically and practically challenging for maternal-fetal medicine specialists and neonatologists alike. The overall goal of this project is to improve antenatal counseling and counseling outcomes for families facing anticipated extremely preterm delivery through innovative, interdisciplinary simulation-based education for maternal fetal medicine specialists and neonatologists, using language preferred by families, and focusing on eliciting values and building partnerships through advanced communication and relational skills. Read Less

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals. Read Less

A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump. Read Less