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Premature Birth clinical trials

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NCT ID: NCT05565287 Enrolling by invitation - Premature Birth Clinical Trials

Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

Start date: March 24, 2021
Phase: N/A
Study type: Interventional

Investigation of the combination of neonatal neurobehaviourism and motor behavior in the assessment and ultra-early physical therapy intervention of premature neonates and parental support.

NCT ID: NCT05542108 Enrolling by invitation - Premature Birth Clinical Trials

Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants

NTM
Start date: September 7, 2021
Phase: N/A
Study type: Interventional

This project is a Randomised Clinical Trial that includes a tactile-kinesthetic somatosensory stimulation or family centred education intervention with families of preterm infants at risk for sensori-motor disorders. This is a study will be based on the adaptation of the intervention previously described and published by Guzzetta and colleagues (2009), and will include an improved and increased kinesthetic component, to be performed in infants born very prematurely and preterm infants with a documented brain injury. The intervention will start in neonatology during the infant hospitalization and continue at the child's home until two months of correct age.

NCT ID: NCT05391633 Enrolling by invitation - Premature Birth Clinical Trials

Maternal Voice and Quantitative EEG (qEEG)

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power density) as a marker of development.

NCT ID: NCT05381272 Enrolling by invitation - Preterm Birth Clinical Trials

Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Infants

Start date: January 1, 2010
Phase:
Study type: Observational

Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality. However, there is few studies on this subject, especially concerning the neurodevelopment outcomes. Objective: to compare neurodevelopmental outcomes at the age of 2 of very preterm infants with antenatal duagnosis of severe and early IUGR in comparison with infants of the same gestational age, same sex and over the same period with no IUGR. Hypothesis : Preterm infants with early and severe antenatal IUGR have more neurodevelopmental delay than infants with no IUGR.

NCT ID: NCT05313464 Enrolling by invitation - Clinical trials for Parent-Child Relations

Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions

PREMIAM
Start date: April 15, 2022
Phase: N/A
Study type: Interventional

Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child. However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown. PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.

NCT ID: NCT05243537 Enrolling by invitation - Preterm Birth Clinical Trials

QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal

Start date: January 1, 2023
Phase:
Study type: Observational

Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the potential QT interval prolongation (all Bazett) in former extreme low birth weight (ELBW, <1000 g) infants or preterms. Consequently, if investigators truly want to assess the presence or absence of either a difference or a prolongation of QTc intervals in this specific population, pooling of published data is likely the most effective approach (potential number of cases = 24 + 49 + 93 = 166; potential number of controls in the same studies = 24 + 53 + 87 = 164), preferably based on individual data. Although the sample is to a large extent pragmatic (as available), the investigators hereby aim to target the 5 ms QTc prolongation applied by the authorities (FDA, EMA) in paired healthy adult volunteer studies as 'golden' standard as primary outcome variable [EMA guideline, FDA guidance].

NCT ID: NCT05231200 Enrolling by invitation - Length of Stay Clinical Trials

Alberta Collaborative QI Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI Trial)

ABC-QI
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The ABC-QI Trial aims to implement collaborative quality improvement (QI) strategies to standardize care for 32-36 week infants in Level 2 and 3 Neonatal intensive care units (NICUs) across the province of Alberta. The investigators want to know if using validated quality improvement methods and evidence-based care bundles will decrease the duration of hospital stay and get babies home as quickly as possible.

NCT ID: NCT05191823 Enrolling by invitation - Preterm Birth Clinical Trials

Omega Tots Long Term Follow-up

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This is a continuation study to the Omega Tots trial (NCT01576783). The purpose of this study is to follow-up with participants of the original study to determine the long-term effect a daily fatty acid dietary supplement taken during toddlerhood might have on children born preterm now that they are 8.5-10.5 years old.

NCT ID: NCT05144282 Enrolling by invitation - Clinical trials for Retinopathy of Prematurity

The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation

Start date: August 15, 2020
Phase:
Study type: Observational [Patient Registry]

Study Aims 1. Understanding the gut microbiome profile in very low birth weight infants with or without ROP. The onset and aggravation of ROP and their relationship with gut microbiome will be examined. 2. Understanding the serum inflammatory cytokine profile in these infants and its relationship with the onset and progression of ROP. Their changes and association with the other systemic disorders such as NEC or RDS or sepsis will be explored. 3. Examiningthe associations amongmicrobiome profile and serum inflammatory cytokines and their relationship with ROP clinical features (prematurity without ROP, ROP without treatment, and ROP with treatment) in the study participant

NCT ID: NCT05011071 Enrolling by invitation - Asthma Clinical Trials

The Alberta BLOOM Premature Child Study

BLOOM-PCS
Start date: October 21, 2021
Phase:
Study type: Observational

This is a prospective, observational clinical cohort study involving 405 children born premature (at less than 37 weeks gestation) and their mother/parent/guardian. The purpose of the study is to investigate how the microbiome (the collection of microbes in a biological site) of children develops over the first years of life and its associations with the risk of childhood health outcomes including allergies and asthma. The study will also examine how perinatal factors associate with patterns of microbiome development, and their effects on the microbiome, metabolome (the collection of metabolites in a biological sample) and immune development of this population in the first years of life.