View clinical trials related to Premature Birth.
Filter by:Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.
This study is planned prospectively in pregnancies who applied to Etlik Zübeyde Hanım Women's Health Care, Training and Research Hospital which is a teritiary hospital with 15.000 births anually, between January 2022 and January 2023. Cerclage treatment will be performed with the McDonald technique (the type of cerclage suture will be mersilene) between the 16-23 weeks of gestation in pregnant women with a diagnosis of cervical insufficiency based on the history , physical examination or ultrasound findings according to ACOG. The investigators will measure cerclage area after cerclage treatment (within 0-4 weeks) and different parameters besides it by transvaginal ultrasound. It will be whether the collected data is related to the incidence of preterm birth.
The purpose of the study is to test the effects of the ezParent (web-based parent training program) intervention and telephone coaching calls (coach) on parent and child outcomes after 3-, 6-, and 12-months. Parents (n=220) will be randomized using a 2 x 2 factorial design to: (1) ezParent+coach, (2) ezParent, (3) Active Control+coach, or (4) Active control. The investigators will address these aims: 1. Determine the independent and combined effects of ezParent and coaching calls on parent outcomes. H1: The ezParent and ezParent+coach groups will report greater improvements in parenting skills and self-efficacy and reductions in harsh and negative discipline; and exhibit observed improvements in parent-child emotional connection vs. active control H2: There will be a synergistic effect of ezParent and coaching calls on parent outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 2. Determine the independent and combined effects of ezParent and coaching calls on child outcomes. H3: The ezParent and ezParent+coach groups will report greater reductions in child behavior problems vs. active control. H4: There will be a synergistic effect of ezParent and coaching calls on child outcomes such that ezParent+coach will provide greater benefit than the sum of the main effects of ezParent or coaching calls. 3. Determine differences in ezParent engagement with and without coaching calls. Engagement will be assessed by frequency (the number of times parents use the program), activity (proportion of material completed), and duration (amount of time parents use the program). H5: Relative to the ezParent only group, the ezParent+coach group will exhibit higher engagement with the ezParent.
A Pragmatic Randomized Controlled Pilot Trial to Evaluate the Impact of Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen in Spontaneously Breathing Late Preterm Newborn Infants Born by Cesarean Delivery, Compared to No Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen, on the Need for Further Respiratory Support Leading to NICU Admissions.
This is an observational, proof-of-concept, feasibility study where 50 preterm infants with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital. The study's primary objective is to describe the relationship between respiratory acoustics and airflow and determine the reliability of a novel respiratory acoustic sensor at detecting breathing sounds in preterm infants. The study's secondary objectives are: 1. To compare transthoracic impedance, respiratory inductive plethysmography and an inertial measurement unit for the detection of respiratory efforts in preterm infants. 2. To evaluate the feasibility and accuracy of a novel, non-invasive method for continuously detecting and differentiating cardiorespiratory events in preterm infants on CPAP by integrating measurements of respiratory effort with respiratory acoustic monitoring.
The goal of this research project is to identify the long-term outcome of neurodevelopment in patients with retinopathy of prematurity(ROP) and the treatment of anti-vascular endothelial growth factor (VEGF) such as intravitreal injection of bevacizumab (IVB), ranibizumab, or aflibercept.Investigators propose this study hopefully to have a better understanding of the long-term safety of anti-VEGF on the treatment of ROP. Studies in both animalsand humans have found evidence of systemic bevacizumab exposure after IVB. In an animal study, IVB at an early age could result in more systemic bevacizumab exposure. Our study has further shown that VEGF levels in ROP infants were depressed for 8 weeks after IVB. VEGF plays an important role in neurogenesis in embryos and preterm newborns. In previous reports, blocking VEGF-A expression has been shown to impair brain vascularization and lead to neuron apoptosis in the retina. In addition, VEGF has been found to be lower in preterm pups compared to term pups, and this has been proposed to relate to the neurodevelopmental delay and reduced growth of the cerebral cortex in premature infants. Since neurogenesis may continue in the third trimester, further inhibition of serum VEGF in preterm newborns may have long-term effects on the development of the central nervous system and other systems. Currently, most studies reported neurodevelopmental outcomes in anti-VEGF treated premature infants before 2 years of age, and only one study reported 5 year outcomes. Our recent study also found that the neurodevelopmental outcomes at the mean age of 1.52 ± 0.59 years after birth were similar between ROP patients who did not require treatment and ROP patients with IVB treatment. Unfortunately, the value of early assessments of cognition in predicting cognitive functioning at school age and older is questionable.Many developmental deficits in cognition, emotional and behavioral development, and social adaptive functioning may emerge at older ages in the absence of neurodevelopmental impairment in toddlerhood. Visuomotor function deficit are also noted at school age in children who had normal development at 3 years of age. The above studies demonstrate a need for longer follow-up of the preterm infants to fully comprehend their neurodevelopmental outcomes. To our knowledge, currently there are no reports of neurodevelopmental outcomes in anti-VEGF treated premature infants beyond 5 years of age. Therefore, investigators propose this study hopefully to have a better understanding of the long-term safety of anti-VEGF on the treatment of ROP. This study will aim at (1) Understanding the long-term neurodevelopmental outcomes of intravitreal injection of anti-VEGF comparing to standard laser treatment for ROP in premature infants. (2) Compare the long-term neurodevelopmental outcomes in premature infants with ROP treated by different anti-VEGF agents. (3) Analysis the long-term ocular morphological and functional outcomes in premature infants with ROP with prior treatments. Investigators plan to recruit patients from our previous ROP cohort, who now aged 3 to12-years-old. Thepatients will be divided to six groups:premature without ROP (Group 0); ROP without treatment (Group 1); ROP with laser photocoagulation treatment (Group 2); ROP with anti-VEGF treatment (Group 3); ROP with laser photocoagulation + anti-VEGF treatment (Group 4); Fullterm (Group 5).Serialneurodevelopmental tests, such as Chinese Child Development Inventory (CCDI), Child Behavior Checklist (CBCL), The Berry-Buktenica Developmental Test of Visual-Motor Integration, Bayley Scales of Infant Development, Wechsler children's intelligence test- fourth editionand other neurocognitive tests and questionnaires, will be performed yearly in all patients. The detailed visual tests, such as best-corrected visual acuity, slit lamp examination, indirect ophthalmoscopy,and optical coherence tomography (OCT) will be performed every 6 months. Main outcome measures will be neurodevelopmental outcomes. The neurodevelopmental outcomes will be analyzed longitudinally and in the cross-section fashion. These outcomes will be compared between the five groups, and in the subgroup analysis. Secondary outcomes will include ocular morphological and functional results of these children. Finally, the correlation of ocular resultswith neurodevelopment outcomes will be analyzed. Investigators are fortunate to have the opportunity of following a longitudinal ROP cohort and monitor their long-term outcomes. In the long-term, this studywill improve understanding the long-term safety of anti-VEGF treatment for ROP, which is a heatedly debated topic. Investigators will also have a better knowledge which anti-VEGF might be safer than the other. Understanding these facts will help us to come up with a better treatment strategy for ROP in the future.
The precise description of parental presence and the associated factors will make it possible to construct an intervention in order to correct potentially low parental participation. The demonstration of the effectiveness of such an intervention will be the subject of a larger study (PHRIP type). Ultimately, the investigators want to personalize the daily support for parents to offer optimal support for parenting.
Effective initial stabilization of preterm neonates in the initial 60 minutes of life ("golden hour") was shown to improve outcomes. Keys components include anticipative and collaborative approach, respiratory support, thermal regulation and early initiation of parenteral nutrition. The objective is to complete the admission within 60 minutes of delivery.
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia. Hypothermia has been defined as a contributor of neonatal morbidity by The World Health Organization. Another acute morbidity is anemia in preterm infants due to the prematurity and frequent laboratory testing. Anemia requires correction with a packed red blood cells (PRBC) transfusion. Researchers have previous noted hypothermia during PRBC transfusions in preterm infants. Objective: To use a commercial blood warmer in the neonatal intensive care setting to prevent hypothermic body temperatures (<36.5°C) in very preterm infants during PRBC transfusions. Process: Based on a completed national survey of neonatal intensive care nurses and PRBC transfusion practices and personal NICU experience, we designed this randomized control trial in 140 very preterm infants in a Southeastern, level III neonatal intensive care unit. Outcomes: Very preterm infants (<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a lower incidence of central body hypothermia post transfusion (temperatures <36.5C), compared to infants receiving PRBC transfusions by standard of care. Very preterm infants (<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a higher post transfusion mean abdominal skin body temperature when compared to infants receiving PRBC transfusions by standard of care. Hypothesis : The results of this trial could show that very preterm infants experience hypothermia during PRBC transfusions, and thus provide the evidence to support the need for warmed PRBC transfusions in very preterm infants nationwide.