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Premature Birth clinical trials

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NCT ID: NCT04123691 Completed - Premature Birth Clinical Trials

Cardio-respiratory Events in Preterm Infants During Transition

Start date: February 21, 2018
Phase:
Study type: Observational

Cardio-respiratory events (CRE), defined as intermittent episodes of hypoxemia and/or bradycardia, are particularly common among preterm infants. It has been previously shown that CRE result in transient brain hypoxia and hypoperfusion and may represent a possible risk factor for neurodevelopmental impairment and retinopathy of prematurity. The high cardio-respiratory instability typically seen in preterm infants during the first 72 hours of life may influence CRE occurrence, with possible clinical implications. This study aims to characterize CRE features in this transitional period and to evaluate whether specific neonatal and clinical characteristics are associated with different CRE types. Newborn infants with gestational age (GA) <32 weeks or birth weight (BW) <1500 g are enrolled. Congenital malformations and mechanical ventilation are exclusion criteria. During the first 72 hours, heart rate (HR) and peripheral oxygen saturation (SpO2) are continuously monitored, and an echocardiogram is performed to assess the status of the ductus arteriosus. CRE are clustered into isolated desaturation (ID, SpO2<85%), isolated bradycardia (IB, HR<100 bpm or <70% baseline), combined desaturation and bradycardia (DB, occurrence of the two events within a 60-sec window). According to their duration and SpO2 and/or HR nadir values, CRE are also classified as mild (SpO2 80-84% and HR 80-100 bpm and duration <60 sec), moderate (SpO2 70-79% or HR 80-60 bpm or duration 61-120 sec) or severe (SpO2 <70% or HR <60 bpm or duration >120 sec). A generalized estimating equation (GEE) will be used to examine the impact of relevant variables on CRE type and severity.

NCT ID: NCT04122417 Completed - Therapeutic Touch Clinical Trials

The Effect Of Therapeutic Touch To Mothers With Preterm Babies

Start date: August 1, 2016
Phase:
Study type: Observational [Patient Registry]

The study was carried to determine the effect of yakson or gentle human touch methods applied by the mothers to their preterm newborns on mother's attachment level and baby's response.

NCT ID: NCT04122300 Completed - Preterm Neonates Clinical Trials

Euphrasia Eye Drops in Preterm Infants With First Signs of Congestion of Nasolacrimal Duct

Euphrasia
Start date: May 22, 2011
Phase: Phase 3
Study type: Interventional

Congenital nasolacrimal duct obstruction (CNLDO) occurs in approximately 10 to 20% of all term newborns, and is the most common cause of persistent tearing and ocular discharge in children. CNLDO causes symptoms in up to 6% of children during the first year of life. The first clinical signs appear during the first month of life in 95% of cases and usually consist of tearing and debris on the eyelashes ("mattering"). Mucopurulent eye discharge occurs commonly in infants with CNLDO and, in the absence of other signs of infection, suggests bacterial overgrowth in the stagnant tear pool of the lacrimal sac. This study investigates whether early administration of Euphrasia eye drops (Weleda AG, Arlesheim) in preterm neonates presenting with first ocular discharge with or without tearing and reddened eye fosters the resolution of the ocular discharge and reduces the need for topical antibiotic therapy.

NCT ID: NCT04121897 Completed - Clinical trials for Parent-Child Relations

Therapist Education and Massage for Parent Infant-Outcomes

TEMPO
Start date: November 25, 2019
Phase: N/A
Study type: Interventional

The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant behavioral-motor development, principles of family-centered care, and multiple modes of educational delivery to enhance parent retention of knowledge, parent-infant bonding, and confidence in continuing physical therapy interventions after discharge.

NCT ID: NCT04101721 Completed - Clinical trials for Retinopathy of Prematurity

Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

BUTTERFLEYE
Start date: October 30, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

NCT ID: NCT04100252 Completed - Clinical trials for Premature Rupture of Membrane

The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes

AFI in PPROM
Start date: September 1, 2018
Phase:
Study type: Observational

Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 and who finally were diagnosed as PPROM were included in the study. Women with multiple gestations, cervical dilatation above 6 cm at the admission, hypertensive diseases, cervical cerclage, fetal anomalies, olgohydramnios, polihydramnios, and those who declined to involve in the study were excluded. In all included women were examined at the admission for amniotic fluid index via trans abdominal ultrasonography. AFI were measured by four quadrant technique, which is sum of the deepest vertical length of pocket of fluid in each quadrant without any umbilical cord. All included patients were assessed in two groups; women with AFI<5 and those with AFI≄5 cm. Included patients were followed in terms of maternal and fetal complications. Maternal complications were chorioamnionitis, placental abruption, placental retention, postpartum endometritis, postpartum hemorrhage; while fetal complications comprised necessity of admission to neonatal intensive care unit, neonatal sepsis, meconium aspiration syndrome, respiratory distress syndrome, intraventricular hemorrhage, umbilical cord pH below 7.10, APGAR score of 5th minute below 5. All complication rates were compared between the groups. In addition, the time period between the diagnosis of PPROM and the time of delivery was defined as latency period and were compared between the groups.

NCT ID: NCT04098289 Completed - Preterm Birth Clinical Trials

Preterm Delivery After Septum Resection

PLEASURE-1
Start date: July 2012
Phase:
Study type: Observational

Uterine septum is the most common congenital uterine malformation. It accounts for approximately 35% of all uterine malformations, while the frequency of uterine malformations in the general fertile population is estimated to be between 1% and 4%. The presence of a uterine septum is associated with subfertility and a high incidence of obstetric complications, such as spontaneous abortion, 3-fold increase in preterm premature rupture of the membranes (PROM), 6-fold increase in preterm delivery, malpresentation at delivery, caesarean section, and increased perinatal morbidity and mortality. Some studies have found that surgical resection of the uterine septum improves pregnancy outcomes and significantly reduces the risk of preterm delivery. Therefore, the risk for a short-term adverse outcome and long-term sequelae due to preterm delivery such as intraventricular hemorrhage, necrotizing enterocolitis, sepsis, patent ductus arteriosus, retinopathy, deafness, chronic lung disease, cerebral palsy, perinatal death, and impaired mental development in women with uterine septum could be lowered by performing a relatively simple and safe hysteroscopic septum resection (HSR). However, there are two major concerns regarding HSR: cervical incompetence due to excessive dilatation during hysteroscopy and the rare yet serious complication of uterine rupture in subsequent pregnancy or delivery. Considering these elements, the aim of this study will be to evaluate the rate of preterm delivery in singleton pregnancy comparing primary infertile women who underwent HSR and who did not undergo the same procedure, with our without in vitro fertilization.

NCT ID: NCT04097548 Completed - Preterm Birth Clinical Trials

A RCT of CenteringPregnancy on Birth Outcomes and Maternal Inflammation

PIINC
Start date: August 8, 2018
Phase: N/A
Study type: Interventional

The purpose of the PIINC study is to identify differences in placental inflammatory lesions between women participating in group prenatal care versus standard prenatal care, and additionally, examine whether the frequency of placental inflammatory lesions differ by race and income. The investigators hypothesize that women participating in group prenatal care will have lower pro-inflammatory profiles compared to women in routine prenatal care.

NCT ID: NCT04095507 Completed - Preterm Labor Clinical Trials

Uterocervical Angle in Patients With Preterm Premature Rupture of the Membranes

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in patients with preterm premature rupture of the membranes

NCT ID: NCT04093492 Completed - Premature Birth Clinical Trials

Preemie Prep For Parents (P3): Home Antenatal Prematurity Education

Start date: February 3, 2020
Phase: N/A
Study type: Interventional

The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to American College of Obstetricians and Gynecologists (ACOG) prematurity patient education handouts.