Active clinical trials for "Premature Birth"

The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).

Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures.

The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.

The objective of this study is to determine, through a randomized clinical trial, whether bed rest is helpful for the management of pregnancies complicated by preterm premature rupture of membranes (PPROM).

The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age. The clinical feasibility and usefulness of implementing these intervention programs within the context of randomized intervention study subject to the existing constraints of the hospital and home settings will be tested in a pilot study. The second aim is to conduct a randomized control trial to examine the costs and effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and socio-economically matched normal full-term infants will also be included as a comparison group. Outcome measures that include child, parenting, and transactions outcomes will be compared between groups. Child outcome measures will include health status, growth, neurodevelopment, and neurosensory status; parenting outcome measures will include maternal parenting competence, social support, and psychological stress; transactions outcome measure will be mother-infant interaction. Costs (direct and indirect costs) associated with each early intervention program during the follow-up period will be estimated. Average and incremental cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.

The purpose of this study is to determine whether beginning an enriched educational/behavioral program for parents of premature infants, very early in the Neonatal Intensive Care Unit (NICU) stay, and lasting until the child is 3 years old, has beneficial results for both the parents and their infants. The hospital phase of the program gives parents an understanding of what to expect in the NICU environment; physical characteristics and needs of their premature baby; and how and when to best support their infant's development during this time. The information given during the home phase of the program continues with information specific to the growth and development and the effective parenting of an infant/toddler who has been born prematurely. It is believed that this information will help decrease parents' stress, anxiety and depression levels that can be related to giving birth to a premature infant. It is also expected that it will strengthen the mother's and father's ability to parent their premature child in a way that will help support their child's brain development and learning ability and to also decrease negative behaviors as the child grows.

The primary objective is to determine if kangaroo holding in the first week after birth influences the stress levels of mothers who have delivered their infants prematurely and who require admission to the Special Care Nursery (SCN). Hypothesis: There will be a decrease in maternal stress levels as perceived by mothers and as reflected in their blood pressures and heart rates after kangaroo holding their premature infants in the SCN.

To determine the safety and efficacy of trans-scleral cryotherapy of the peripheral retina in certain low birth-weight infants with retinopathy of prematurity (ROP) for reducing blindness from ROP. To determine the long-term outcome for eyes that had severe ("threshold") ROP, both with and without cryotherapy.

The FOUNDATION study will evaluate the tolerability of feeding preterm infants a B. infantis probiotic (EVC001) as the primary endpoint. This particular strain of Bifidobacterium has been shown to uniquely utilize oligosaccharides found in human breast milk, possibly providing a nutritional benefit for the infant consuming breast milk when B. infantis is colonized in the gut.

Antepartum bed rest is widely prescribed after preterm premature rupture of the membranes (PPROM), although its effectiveness to prevent preterm birth has not been demonstrated. This pilot randomized controled trial (RCT) aims to access the impact of bed rest in maternal and neonatal outcomes in pregnancies complicated by premature rupture of the membranes.