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Premature Birth clinical trials

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NCT ID: NCT02952950 Completed - Premature Birth Clinical Trials

Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study

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

In this project three studies examined two possible explanations and one possible preventive intervention to early cessation of exclusively breastfeeding in premature infants. Study 1 The content of protein in the milk of mothers, who delivers prematurely, is about a third higher than in the milk from the mother who delivers on time. The nutritional composition changes over time and the content of protein decrease. Therefore the premature infant is at risk of protein deficiency. While the infant is feeding by tube this decreasing content of protein can made up by adding, while it is more difficult when the infant is exclusively breastfeeding. The hypothesis is that reduced protein content in breast milk is associated to a fewer number of days where the premature infant is exclusively breastfed. Study 2 The premature infant is characterized with immature muscle with a low tension and therefore, a low ability to eat its needs by breastfeeding the first period. The transfer of milk from mother to child is an interaction between the mothers and her milk ejection reflex that establish a positive pressure on the milk and the child that have to establish a vacuum. The hypothesis is that the premature infants suction power is too weak to establish sufficient intraoral vacuum to ensure milk transfer from the breast to the infant and it can be related to a fewer number of days where the infant is exclusively breastfed. Study 3 The premature infants low muscle tone and its immaturity also influence on the organization and the quality of movements, marked as neuro motor processes. These processes form the oral motor base supporting movement which involves the infant ability to establish vacuum. The hypothesis is that Oral Stimulation for a specific program in 5 minutes before the minimum 2 meals per. day for at least 14 days increases the preterm infant's ability to create intra oral vacuum and thus the power to transfer milk from the breast, thereby extending the number of days when the infant is exclusively breastfed. 200 infants are included consecutively, as a recurring cohort in all 3 studies. In Study 1 the mothers' milk is analyzed in order to the content of protein. In Study 2 the infant suction is assessed by vacuum measurement. In study 3 the families are randomized to an intervention or control group and parents off 100 infants are guided by occupational therapists in a program of oral stimulation of their child.

NCT ID: NCT02941185 Completed - Clinical trials for Vitamin D Deficiency

Multi-dose Vitamin D Supplementation in Preterm Infants

Start date: January 2014
Phase: Phase 4
Study type: Interventional

Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.

NCT ID: NCT02939495 Completed - Clinical trials for Erectile Dysfunction

The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy

DAP-SPEED
Start date: October 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Dapoxetine/Sildenafil 30/50 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.

NCT ID: NCT02929953 Completed - Clinical trials for Type 1 Diabetes Mellitus

Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients

T1Dpremies
Start date: January 2014
Phase:
Study type: Observational

The aims of this study are: 1. To assess the prevalence of prematurity, especially early prematurity, among T1D patients, and compare it to the prematurity prevalence among the non-diabetic general population in Israel. 2. To characterize epidemiological and clinical factors that differ between premature-born patients that developed T1D and those that have not, including the nutritional and therapeutic properties in NICU.

NCT ID: NCT02924285 Completed - Heart Diseases Clinical Trials

Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease

CAT-PVC
Start date: November 1, 2017
Phase: Phase 3
Study type: Interventional

For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with structural heart disease the current European Guidelines for the management of patients with ventricular arrhythmias and the prevention of second cardiac death recommend catheter ablation as well as amiodarone with a class IIa indication. Due to the lack of randomized data this study investigates the comparison of catheter ablation and amiodarone for PVC treatment in patients with structural heart disease. Therefore, patients will be randomized to one of two treatment strategies: 1) catheter ablation, or 2) amiodarone.

NCT ID: NCT02919540 Completed - Premature Neonate Clinical Trials

Effect of "Kangaroo Mother Care" on Premature Infants Physiological Outcomes

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

This project aims at testing the effect of applying the KMC on the premature infants' physiological outcomes. The findings of this project are expected to contribute to the discipline of preterm infants' care by providing evidence of the benefits, barriers, and facilities of providing the KMC in our Jordanian NICUs.

NCT ID: NCT02915549 Completed - Clinical trials for Premature; Infant, Light-for-dates

Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial

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

To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.

NCT ID: NCT02913495 Completed - Premature Birth Clinical Trials

Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

VIP
Start date: September 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.

NCT ID: NCT02907632 Completed - Clinical trials for Gastroesophageal Reflux

Methoclopramide for Gastroesophageal Reflux in Premature Infants

Start date: April 26, 2017
Phase: Phase 4
Study type: Interventional

Gastroesophageal Reflux (GER) is a condition that affects the majority of premature infants that are followed at the Kangaroo Mother Care Program (ambulatory program for preterm infants discharged with their mothers in continuous skin to skin contact and strict outpatient follow up). For over 20 years, the use of Metoclopramide has been systematic among all preterm infants according to the protocols of the Kangaroo Mother Care (KMC) Program . The aim of this clinical trial is to evaluate the effectiveness and security of metoclopramide to lessen the symptoms of GRE in premature infants that are followed and treated in the Ambulatory KMC Program before 40 weeks of gestational age. Design: Randomized, double blind trial, controlled with placebo. Eligible Population: Premature infants that are followed and treated in the Ambulatory Kangaroo Mother Care Program at Hospital Universitario San Ignacio before 40 weeks of gestational age, which systematically receive: metoclopramide 0.2 mg per kg, every 8 hours, 15 minutes before every feeding up to 40 weeks of gestational age, between January 01 2017 and December 31 2017.Outcomes: Incidence of regurgitation episodes reported by the parents of the infants, episodes of apnea, bronchoaspiration, postprandial irritability, the infant rejects feeding, alteration in the postprandial posture and the frequency and severity of adverse effects associated with the use of Metoclopramide such as extrapyramidal symptoms and sedation. In the case of continuous variables, the mean and median will be compared according to the distribution and for nominal variables, a chi squared test or fisher test will be carried out. Duration: 12 months. Ethical Aspects: Experiment with minimum mayor risk. Informed consent will be requested to parents. An independent committee from the work group will be in charge of carrying out the follow-up of the safety and progression of the study. A methodological expert, a thematic expert, a statistician and an expert in bioethics will constitute the committee. Financial Disclosure: The study will be funded through the Kangaroo Foundation with the collaboration of the " Hospital Universitario San Ignacio", Bogotá, Colombia.

NCT ID: NCT02901795 Completed - Clinical trials for Fetal Membranes, Premature Rupture

Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes

AiRPM
Start date: November 2, 2018
Phase:
Study type: Observational

All included patients will have their fetal heart rate recording performed with an EDAN F3 fetal monitor that allowed the back up recording of the fetal heart rate beat to beat detection. Fetal heart rate variability analysis will be performed using Matalb® software.