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Premature Birth clinical trials

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NCT ID: NCT02096822 Completed - Preterm Clinical Trials

Efficacy of Facilitated Tucking During Pain Procedure in Preterm Infants

BABYDOUL
Start date: April 2014
Phase: N/A
Study type: Interventional

Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.

NCT ID: NCT02092688 Completed - Preterm Birth Clinical Trials

Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth

Start date: December 2013
Phase:
Study type: Observational

This is a prospective observational trial that will enroll pregnant women between 24 and 36 6/7 weeks of gestation that present with signs and symptom of preterm labor with clinically intact membranes and cervical dilatation ≤ 3 cm and a control group of pregnant women without signs and risks for PTL to assess how the results of the novel kit for the detection of PAMG-1 in both patient groups correlate to their time-to-delivery (TTD) and other adverse neonatal and pregnancy outcomes. Thes study hypothesis contains that the novel diagnostic kit will identify women who are at high risk for preterm birth by a high positive predictive value.

NCT ID: NCT02092103 Completed - Premature Birth Clinical Trials

Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

Start date: March 2014
Phase: N/A
Study type: Interventional

This is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage, and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping is superior to simply delayed cord clamping, presumably providing an increased blood volume to the preterm neonate improving its outcomes.

NCT ID: NCT02090920 Completed - Preterm Labor Clinical Trials

Individualized Dosing of Nifedipine For Tocolysis in Preterm Labor

Start date: July 2011
Phase:
Study type: Observational

This study looks at the effects of a mother's genes and other characteristics (mother's age, baby's age, race, and other diseases) on the ability of nifedipine to end contractions and prevent an early delivery. This information will be used to decide what amount of nifedipine women need to best treat preterm contractions.

NCT ID: NCT02076126 Completed - Premature Birth Clinical Trials

Determination of Lung Maturity and Prediction of RDS at Birth

Start date: March 2014
Phase: N/A
Study type: Observational

The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment. We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.

NCT ID: NCT02074774 Completed - Clinical trials for Oxygen Titration in Preterm Infants to Manage Lung Disease

IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

Start date: December 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02073071 Completed - Clinical trials for Other Preterm Infants

Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants

Start date: May 2014
Phase: N/A
Study type: Observational

This is a two stage open-label, single-arm, multicenter and observational study.

NCT ID: NCT02059304 Completed - Preterm Delivery Clinical Trials

Prediction of Preterm Deliveries by Cervical Length Measurement With Embryo Transfer Catheter in ICSI Patients

Start date: January 2012
Phase: N/A
Study type: Interventional

The aim of this study is to examine the potential value of cervical length (CL) measurement with embryo transfer catheter in the prediction of spontaneous preterm deliveries in intracytoplasmic sperm injection (ICSI) cycles. Preterm birth is the leading cause of perinatal death and handicap in children. It is clear that ICSI pregnancies are at high risk groupfor preterm delivery (PTD). In singletons there is an estimated two-fold increased risk following ICSI. CL measurement with ultrasound in mid-trimester (22-24 weeks) is the best method for the prediction of PTD: The shorter the CL, the higher risk of PTD. Recent evidence suggests that at first trimester (11-13 weeks), the risk for PTD is inversely related to CL. It has been shown that the measurement of CL on pregnancy is an effective method for identification of the group at high risk for PTD. In embryo transfer, catheter is placed the through cervical canal. The method we will use in this study, CL measurement with transfer catheter, will give more precise results than measurement with ultrasound. No study has been performed to evaluate the prediction of PTD by analyzing measurements of CL, preconceptionally. Our study will be the first in this topic. There is a certain disadvantage of measuring CL during pregnancy: The effectiveness of prophylactic administrations (progesterone, cervical cerclage etc.) may be inversely related to the gestation at which treatment is initiated. If we know the risk of PTD before gestation, single embryo transfer will be preferred to avoid from multiple pregnancies that also increase the relative risk of PTD, in ICSI pregnancies.

NCT ID: NCT02056899 Completed - Clinical trials for Preterm Labor, Premature Birth

Maintenance Gabapentin to Prolong Pregnancy.

Start date: June 2013
Phase: Phase 1
Study type: Interventional

This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin therapy on the rate of premature birth in women who have had preterm labor.

NCT ID: NCT02056652 Completed - Preterm Birth Clinical Trials

Prevention of Preterm Birth With a Pessary in Singleton Gestations

PoPPS
Start date: February 2014
Phase: N/A
Study type: Interventional

Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.