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Asphyxia Neonatorum clinical trials

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NCT ID: NCT01751945 Completed - Sepsis Clinical Trials

Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project

EmONC
Start date: November 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal mortality.

NCT ID: NCT01743742 Completed - Birth Asphyxia Clinical Trials

First-day High Dose Vitamin C, E in Severe Birth Asphyxia

CEBA
Start date: May 2013
Phase: Phase 4
Study type: Interventional

To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.

NCT ID: NCT01639027 Completed - Labor Pain Clinical Trials

Drotaverine to Shorten the Length of Labor

Start date: May 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being, and for the providers of the birth services. Avoiding along, protracted labor entails shorter exposure to pain, anxiety and stress and would thus translate into a major improvement in maternal satisfaction with the childbirth experience. Based on the premise that shortening the length of labor is beneficial, interventions aimed at accelerating the progression of labor have been introduced routinely as part of standard labor management and care throughout the 20th century. Certain labor accelerative procedures, such as amniotomy, became common practice and have been put to the acid test of randomized control trials to evaluate their efficacy. Use of anticholinergics/antispasmodics as a method of augmenting labor was first described in 1937 by Hirsch, who reported a decrease in labor length by two to four hours following Intrapartum administration of an atropine-like drug (Syntropan®)mainly among older nulliparas. Drotaverine, an isoquinolone derivative is a superior smooth muscle relaxant which acts specifically on spastic sites and corrects the cAMP and calcium balance relieving smooth muscle spasm. This inhibitory action is detected only in lower uterine segment during labor since muscle fibers in upper uterine segment are strongly affected by contractile effect of oxytocin. Use of drotaverine during pregnancy is free of any teratogenic and embryotoxic effects. The Research question is: Does the use of antispasmodic Drotaverine shorten the duration of active first stage of labor in nulliparous women as compared to placebo?

NCT ID: NCT01626924 Terminated - Perinatal Asphyxia Clinical Trials

A Study of 2-Iminobiotin in Neonates With Perinatal Asphyxia

Start date: June 2012
Phase: Phase 2
Study type: Interventional

In case of insufficient oxygen supply to the brain of a newborn child (perinatal asphyxia), toxic compounds will be formed. These toxic compounds will damage the cells of the brain. 2 Iminobiotin (2 IB) is an investigational medicinal product that is related to vitamin B7. From studies in animals it has been shown that 2-IB may prevent the formation of the toxic compounds. Also it has been shown to be safe in in studies in juvenile animals and in healthy, adult male volunteers. The doctors hope that this will prevent (part of) the potential brain damage that may result from lack of oxygen to the brain. This study is the first study in the target population: newborn with moderate to severe oxygen shortage during birth. In this study the investigators evaluate short term efficacy, safety and pharmacokinetics of 2-Iminobiotin. In the follow-up phase the investigators evaluate the long term efficacy and safety. The study hypothesis is that 2-Iminobiotin will help to decrease the brain damage after oxygen shortage and is indeed safe. The brain damage will be measured both in the first week and during the first two years of life. The study was designed as a study with two parts an open label pilot part (6 patients) and a double-blind randomised part (60 patients). Due to lack of recruitment it was decided in September2014 to stop recruitment after the open label pilot part of the study (6 patients).

NCT ID: NCT01550913 Completed - Clinical trials for Perinatal Depression, Substance Use

Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT) in treating women with depression and comorbid substance abuse.

NCT ID: NCT01350765 Completed - Neonatal Sepsis Clinical Trials

Naushero Feroze Neonatal Survival Project

AKU
Start date: March 2010
Phase: N/A
Study type: Interventional

The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan. A team of Lady Health Workers and a Traditional Birth Attendant will provide care to the mothers and newborns at household level. A Basic Health Unit will take care of non complicated referrals and provide injectable antibiotics for neonatal sepsis. Complicated (definitions given in methods section) cases will be referred by the LHWs/BHUs to the District Headquarter Hospital which will have a functioning neonatal care unit. The District Health Services, Naushero Feroz, Provincial Department of Health, Sindh and the Federal Ministry of Health are study collaborators, therefore, guaranteeing scaling up of interventions at national level. Hypothesis: In comparison to a basic package of existing training program of LHWs, enhanced training of LHWs and TBAs in the early recognition and management of birth asphyxia, serious newborn infections and LBW (combined with prompt referral) will result in an additional 30% reduction in neonatal mortality.

NCT ID: NCT01284673 Completed - Clinical trials for Respiratory Distress Syndrome

Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia

NEOCORD
Start date: April 2010
Phase: N/A
Study type: Interventional

Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss. For the moment, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions. Cord blood stem cells are a promising treatment for the near future. However, before conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of neonatal asphyxia, compared to normal situation, is needed. The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. Secondary objectives are to assess such characteristics in conditions of cryo-preservation, compared to fresh cell preparation

NCT ID: NCT01045655 Completed - Depression Clinical Trials

MOMCare: Culturally Relevant Treatment Services for Perinatal Depression

MOMCare
Start date: January 2010
Phase: N/A
Study type: Interventional

The study will evaluate the effectiveness of a culturally relevant, multi-component intervention for antenatal depression. The intervention includes an engagement session, and the woman's choice of brief interpersonal psychotherapy and/or pharmacotherapy in a stepped care treatment for depression model.

NCT ID: NCT00945789 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)

Start date: October 2007
Phase: Phase 1/Phase 2
Study type: Interventional

In this prospective trial the investigators plan to study the efficacy of erythropoietin as a therapeutic agent in neonates who suffer from brain injury following perinatal asphyxia.

NCT ID: NCT00804739 Completed - Clinical trials for Postpartum Depression

Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase

MITT
Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of this project is to test whether a new model of collaborative care depression treatment adapted to the needs and preferences of low-income, urban mothers with perinatal depression and to a pediatric clinic setting increases engagement in and adherence to perinatal depression treatment.