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Infant, Extremely Premature clinical trials

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NCT ID: NCT05685745 Recruiting - Premature Birth Clinical Trials

Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

NCT ID: NCT05612919 Not yet recruiting - Clinical trials for Erythrocyte Transfusion

Red Blood Cells From Umbilical Cord for Transfusion of Preterm Infants

Start date: January 2023
Phase: N/A
Study type: Interventional

This study has been designed to demonstrate that red blood cell from umbilical cord blood (UCB-RBC) is a safe and available product for extremely preterm infants (EPI) transfusion and that transfusion of UCB-RBC is non-less effective than RBC from adult donor for the treatment of anemia of prematurity in this group of patients.

NCT ID: NCT05364385 Recruiting - Acute Lung Injury Clinical Trials

Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease

STOPCLD
Start date: December 2, 2019
Phase: Phase 4
Study type: Interventional

Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation and mitigate acute lung injury.

NCT ID: NCT04641000 Terminated - Asthma Clinical Trials

The Alberta BLOOM Long Term Follow Up Study

BLOOM-LTFU
Start date: November 20, 2020
Phase:
Study type: Observational

This is a prospective, observational clinical cohort study involving children born very preterm at less than 31 weeks and six days gestation. The purpose of this study is to investigate the microbiome (the collection of microbes in a biological site) alternations resulting from preterm birth and associations with the risk of immune dysregulation, asthma and allergies.

NCT ID: NCT04158206 Completed - Pain Clinical Trials

Maternal Voice on Alleviating Pain in Premature Undergoing Heel Lance Procedure and Enhancing Mother-Infant Bonding

Start date: March 20, 2019
Phase: N/A
Study type: Interventional

A total of 64 preterm infants born before 37 weeks of gestation and their mothers were randomly assigned to the experimental and control groups. The intervention used in the experimental group involved an audio recording with repeated clips of the mother reading a children's book, edited to a duration of 13 minutes. The research commenced on the fourth day after the birth of the research subjects, in which the maternal voice recording was played to infants during heel lance procedure once a day for 3 consecutive days. The infants in the control group received general routine care during heel lance procedure. Physiological indicators, including heart rate, respiratory rate, oxygen saturation, and pain response assessed using the Neonatal Infants Pain Scale (NIPS), were recorded 3 minutes before, during, and at the first and 10th minute after heel lance procedure. From the fourth to the sixth day after birth, video recordings of the research process were made and sent to the mother for viewing. On the seventh day after birth, the effectiveness of mother-infant bonding was evaluated using the Mother-Infant Bonding Inventory (MIBI).

NCT ID: NCT03770741 Completed - Brain Injuries Clinical Trials

Safeguarding the Brain of Our Smallest Infants Phase III

SafeBoosC
Start date: June 20, 2019
Phase: N/A
Study type: Interventional

the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual. The hypothesis is that treatment based on near-infrared spectroscopy monitoring for extremely preterm infants during the first 72 hours of life will result in a reduction in severe brain injury or death at 36 weeks postmenstrual age.

NCT ID: NCT03403894 Completed - Clinical trials for Infant, Extremely Premature

Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea

Start date: November 10, 2018
Phase:
Study type: Observational

Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity. In most cases, a child born before 24 years of age is stillborn, but in about one in three cases, it shows signs of life such as heartbeat, breathing, gasps or limb movements. With these too small children showing signs of life, three attitudes are possible: doing nothing and waiting for this life to stop by themselves, setting up palliative care to ensure the child's comfort, or administering a medication to shorten his or her life. The attitude to have is not univocal and the feeling of the teams confronted with their management is difficult even if the goal of the caregivers is always to act as best as possible. The main objective of the study is to describe the clinical state of the child and the practices implemented in the birth room at the Nice University Hospital when children showing signs of life before 24 weeks of amenorrhea are born. The secondary objective is to describe caregivers' experiences, their experiences of these situations and attitudes towards children and their parents, and to identify ethical dilemmas in these situations. This study is an observational cohort study including all births of live children before 24 weeks of amenorrhea at Nice University Hospital for 12 months. It consists of two parts: a quantitative study describing the child's condition and caregiving practices, and a qualitative study of caregivers' experiences and the determinants of their attitudes towards the child. The investigator will coordinate the collection of the data necessary to conduct the quantitative study, and then conduct individual semi-directive interviews with each of the caregivers present at the birth of the child. The qualitative study will be based on the analysis of these interviews.

NCT ID: NCT01666847 Completed - Clinical trials for Infant, Extremely Premature

Milking the Umbilical Cord for Extreme Preterm Infants

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

Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. Milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). In this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. Participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. Data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. The data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months. The hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.

NCT ID: NCT01158391 Active, not recruiting - Length of Stay Clinical Trials

Trial of Patterned Oral Somatosensory Entrainment for Shortening Time to Oral Feeding

Start date: May 2010
Phase: N/A
Study type: Interventional

The primary hypothesis is that the preterm infants (26 0/7 to 30 6/7 weeks gestational age) who undergo the NTrainer System® training will transition to full oral feeds faster than the control group (i.e. the study group will be superior to the control). The secondary hypothesis is that the infants in the NTrainer System® experimental group will have shorter lengths of stay.