Active clinical trials for "Premature Birth"

The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.

A. Specific Aims Premature infants admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) known to cause pain [1]. Through funding from NINR, the investigators found that TDPs not only caused pain but also increased markers of ATP degradation and oxidative stress[2[. The TDP was tape removal, a commonly performed procedure in the NICU2. Based on this finding, the investigators sought to determine if interventions that relieve pain also reduce biochemical markers of ATP degradation and oxidative stress. The investigators first examined the effect of oral sucrose, a commonly used intervention, when given before a heel lance. The investigators chose heel lance because it is the most predominant painful procedure in the NICU, as shown in 29 different clinical trials[3]. The investigators hypothesized that since oral sucrose is documented to significantly reduce pain scores, then administration of this analgesic will also decrease markers of ATP degradation and oxidative stress. However,the investigators observed the opposite effect. Although a single dose of oral sucrose reduced behavioral markers of pain, it significantly increased biochemical markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) over time[4]. More importantly, the effect of oral sucrose on breakdown markers of ATP were enhanced and were significantly higher in neonates that were intubated or were receiving more than 30% FiO25. These findings lead to the question: If oral sucrose does not effectively reduce the biochemical effects of procedural pain, what intervention or groups of intervention will decrease both behavioral markers of procedural pain and reduce ATP utilization and oxidative stress in premature neonates? For this RO1 renewal, the investigators propose to test the individual and additive effects of two commonly used interventions for procedural pain. These interventions are (a) administration of 30% oral glucose and non-nutritive sucking (NNS) (b) facilitated tucking and NNS c) administration of 30% oral glucose, facilitated tucking and NNS. Administration of 30% oral glucose was documented to decreased procedural pain scores[6-9] without the potential adverse effects of fructose, a key ingredient of sucrose[10-11]. Facilitated tucking is the gentle positioning of preterm infants with arms and legs in a flexed, midline position close to the body, while either in a side-lying or prone position[12]. Because tachycardia often accompanies pain, a documented benefit of facilitated tucking is stabilization of heart rate and reduction of motor activity (flailing)[12-13]. Non-nutritive sucking refers to the provision of a weight-appropriate pacifier[14]. The painful procedure will be a clinically required heel lance, which refers to the puncture of a newborn's heel for blood glucose using a specially designed lancet. Our general hypothesis is that commonly used clinical interventions known to reduce procedural pain alter biochemical markers of ATP degradation, oxidative stress and cell injury. Specific Aim 1 will determine whether (a) 30% oral glucose and NNS or (b) facilitated tucking and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease procedural pain. • Pain will be quantified using a validated pain scoring tool, the Premature Infant Pain Profile (PIPP). Individual and additive effect of interventions will be determined. Specific Aim 2 will determine whether (a) 30% oral glucose and NNS or (b) facilitated tucking and NNS or (c) 30% oral glucose with facilitated tucking and NNS will decrease biochemical markers of ATP degradation, oxidative stress and oxidative cell injury. Products of ATP breakdown in plasma-hypoxanthine (Hx), xanthine (Xa), and uric acid (UA)-will be measured using high performance liquid chromatography. Oxidative stress will be quantified by measuring plasma levels of allantoin using mass spectrometry. Cell injury will be quantified by measuring plasma levels of F2 isoprostane using liquid-chromatography/mass spectrometry.

The purpose of this study is to examine the effectiveness of focused family planning counseling on the uptake and continuation of highly effective contraceptive methods (defined as the intrauterine device, implant, and both male and female sterilization methods including vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently experienced a preterm delivery. The investigators hypothesize that women with a recent preterm birth (PTB) will be more likely to initiate and continue using a highly effective method of contraception when provided with focused family planning counseling.

The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.

Previous studies have suggested that premature luteinization (PL)during controlled ovarian stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium receptivity. This study aims to describe the impact on endometrial gene expression of PL in GnRH antagonist and GnRH agonist cycles.

Vascular Endothelial Growth Factor (VEGF) is a dimeric glycoprotein, naturally expressed in epithelial and tumor cells (1). Normal Retinal vascularization has two phases: In the first fase, cells of mesenquimatous origin form the first superficial plexus (14-21 weeks of gestation). In the second phase, denominated "angiogenesis phase", the superficial and deep capillary plexus are formed (15,20). The Retinopathy of Prematurity (ROP) was described for the first time in 1942 (4), at the present moment it is a public health problem in the developing countries. The International Classification of ROP classifies it in 5 stages, dividing it in 3 anatomical zones. It is a public health problem that continuous without having an effective prophylaxis. The early diagnosis and treatment in thresholds stages have changed the prognosis of this disease (11,12).

Preterm birth remains a major cause of perinatal morbidity and mortality in developing as well as in developed countries. Despite major clinical research efforts aimed at reducing the incidence of preterm births in the United States, the preterm birth rate reached its highest level in 2 decades, 11.9% in 2001, which translates to a 27% rise since 1981. Much of this increase may be accounted for by the increase in multiple gestations brought about by assisted reproductive technology. Twin gestations accounting for 20% to 25% of all pregnancies conceived following such procedures. Twin gestations are at a particularly increased risk of preterm labor and they deliver at a mean gestational age of 37 weeks compared to 40 weeks for singleton pregnancies. In a study by our group, we estimated that about 54.5% of twin gestations would deliver prior to 37 completed weeks of gestation; i.e. preterm. Evidence regarding efficacy of interventions designed to prevent preterm birth has been disappointing. Most well-designed clinical trials have failed to demonstrate any reduction in preterm births with such interventions as home uterine activity monitoring, reduced physical activity, administration of antibiotic or tocolytic therapy, and intensive and frequent antenatal follow ups. Recently, progesterone has shown some promise in the prevention of preterm birth among women with prior preterm births. Whether this intervention will prove effective in other populations, such as women with multiple gestations, remains to be seen. The objective of our study is to compare the effectiveness of weekly intramuscular injections of 17-alpha Hydroxyprogesterone Caproate, a natural metabolite of progesterone, in preventing delivery at less than 37 weeks of gestation in a population of 290 patients with twin gestations between 16 and 36 weeks of gestation compared to a placebo. The data generated will be invaluable in managing this group of patients that is considered at a very high risk for preterm labor and delivery.

The purpose of the current study is to investigate the effect of using cup feeding for preterm infants during NICU stay on breastfeeding outcomes after discharge. The following hypotheses are being tested: Infants Fed by cup during NICU stay will have higher breastfeeding proportions than infants fed by bottle Infants fed by cup during NICU stay will have higher breastfeeding behaviour score on the Preterm Infant Breastfeeding Behavior Scale than infants fed by bottle

The research was planned in a randomized controlled experimental design to determine the effects of the cup and bottle used during the first oral feeding on physiological characteristics and feeding performance in preterm infants. The research was carried out between January 2021 and February 2022 at the Neonatal Intensive Care Unit of Göztepe Süleyman Yalçın City Hospital. Research data were obtained from preterm infants who were born before 34 weeks of gestation, appropriate to selection of study group criterias and hospitalized in the neonatal intensive care unit. A total of 80 babies in the sample group were randomly assigned to the experimental (bottle) and control (cup) groups. Oxygen saturation, heart rate, feeding performance and test weight before, during and after feeding of preterms in both groups were compared. There was no statistically significantly difference between the experimental and control groups in terms of oxygen saturation and heart rate.

Objectives: Kangaroo care is a safe and effective alternative method to conventional neonatal care for newborn babies. The aim of this study was to evaluate the effect of kangaroo care on the transition time to full oral feeding in preterm infants fed by gavage. Methods: This is a randomized controlled trial. This study was conducted in a level III neonatal intensive care unit of a university hospital in eastern Turkey 50 premature babies with a birth weight of ≥ 1000 g and a gestational age of 27-36 weeks, and their mothers were included in the study. The cases were randomly divided into two groups: kangaroo care, which would be applied up to five days a week, and standard care. Records of cases were kept regularly from their hospitalization until they reached full oral feeding.