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Preterm Infant clinical trials

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NCT ID: NCT03555981 Terminated - Death Clinical Trials

Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates

eKMC
Start date: May 20, 2018
Phase: N/A
Study type: Interventional

The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known. This pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous Kangaroo Mother Care (KMC) compared to standard care in mild-moderately unstable neonates <2000g in a resource limited hospital setting.

NCT ID: NCT03552510 Completed - Preterm Infant Clinical Trials

Oropharyngeal Administration of Mother's Milk in Preterm Infants and Gastrointestinal Motility

OPAMM
Start date: June 1, 2016
Phase: N/A
Study type: Interventional

Mother's milk does not come in contact with the oropharyngeal pouch of preterm infants during gavage feeding. We hypothesized that stimulation of the oropharyngeal pouch using small amount of the mother's milk 5 minutes before initiation of regular gavage feeding will increase the level of GIT hormones.

NCT ID: NCT03551314 Completed - Preterm Infant Clinical Trials

Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates

Start date: May 26, 2017
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation.

NCT ID: NCT03518762 Completed - Preterm Infant Clinical Trials

Sustained Lung Inflation in Preterm Infants

Start date: December 21, 2014
Phase: N/A
Study type: Interventional

This is a randomized controlled study to investigate the effect of application of sustained lung inflation (SLI) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.

NCT ID: NCT03518736 Active, not recruiting - Cerebral Palsy Clinical Trials

Does Timing Matter? Supporting Play, Exploration, and Early Developmental Intervention

TimeSPEEDI2
Start date: February 6, 2019
Phase: N/A
Study type: Interventional

Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities. Impairment including reduced postural control, movement variability, visual motor skills, and motor learning are common during the first months of life and are associated with later developmental disabilities. However, infant born very preterm rarely receive evidence based therapeutic intervention in the first months of life when basic science and animal intervention studies suggest the greatest efficacy. Barriers to enrollment in services delay the onset of services and delivery models rarely support targeted preventative intervention or enhanced parent engagement during in the transition from the neonatal intensive care unit (NICU) to home. Targeted intervention supporting postural control and motor learning in the NICU have resulted in short term motor gains. Interventions that enhance parent's ability to read their infant's cues and provide engagement opportunities improve maternal mental health and infant social and cognitive outcomes in the short-term. The purpose of this randomized clinical trial is to evaluate the efficacy of an intervention that combines evidence based motor intervention and parent engagement to enhance the parent's ability to provide daily motor and cognitive opportunities resulting in improved motor and cognitive outcomes. Supporting Play Exploration and Development Intervention (SPEEDI) uses guided participation to empower parents in reading infant's behavioral cues, identifying ideal times for interaction, and enriching the environment and learning opportunities. Parents participate in 5 session in 3 weeks while learning principles of engagement, readiness for interaction, and to provide early motor and cognitive learning opportunities. Parents provide 20 minutes of motor and cognitive play based enrichment daily for 12 weeks with bi-weekly physical therapist support. The parent is empowered to determine the infant's current abilities and advance the activities to the "Just Right Challenge" throughout the 12 weeks, likely continuing after the intervention. The efficacy of SPEEDI will be assessed during delivery at 2 time point; the transition from the NICU to home (around the infant's due date) and at 3-4 months of adjusted age (after the infants due date). Ninety infants will be randomly assigned to a Usual Care group, SPEEDI_Early, or SPEEDI_Later group. Group differences will be assessed in developmental outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler Development as well as the Early Problem Solving Indicator and Gross Motor Function Measure at the end of each intervention period, 12 and 24 months of age.

NCT ID: NCT03513146 Completed - Preterm Infant Clinical Trials

Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection

OPAMM
Start date: May 1, 2016
Phase: N/A
Study type: Interventional

The protective effect of mother's milk and colostrum on oropharyngeal cavity is not achievable with gavage feeding. This may be increase the risk of colonization of the oropharyngeal cavity with pathogenic bacteria and subsequent increase in the risk of neonatal sepsis. We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM) before gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm infants with pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM on the incidence of nosocomial sepsis.

NCT ID: NCT03512158 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Non-invasive Respiratory Support in Preterm Infants

NOVEL
Start date: May 15, 2018
Phase: N/A
Study type: Interventional

Lungs of babies born early are not fully developed and they often need a machine to help them breathe. The traditional approach to provide this support is with a breathing tube passed into the windpipe. However, we know that breathing tubes can cause injury to the fragile lungs of premature babies. Providing breathing support through nose-masks instead of breathing tubes (called nasal breathing support) is becoming popular, as it is gentler on developing lungs. Doctors, in trying to limit the use of support with a breathing tube, are using many different forms of nasal breathing support. The most common form is nasal continuous positive airway pressure (CPAP) which delivers a constant pressure and the baby breathes on his on her own. However, when this strategy is no longer able to support a premature baby's breathing, the best way to provide breathing support is not known. Some doctors use a strategy called "nasal intermittent positive airway pressure" (NIPPV) which gives the baby artificial breaths through the nose-mask. Others simply increase the pressure on nasal CPAP to higher than traditional levels. In the first study of its kind, we will compare these two strategies of nasal breathing support given to premature babies.

NCT ID: NCT03512093 Completed - Preterm Birth Clinical Trials

Improving SCBU Care for Preterm Babies

PretermBabies
Start date: May 1, 2018
Phase:
Study type: Observational

Since 2008, preterm neonates are taking care of in a Special Baby Care Unit (SCBU). Those born less than 34 weeks of gestation are followed-up monthly for one year for monitoring their hematocrit level, growth and development. Medical chart reviews are useful to evaluate the burden of diseases, characterize care treatment patterns and clinical outcomes by patients' subgroups; ultimately it can help identifying gaps in care pathways thus improving quality of care and ultimately reducing mortality. Medical records of all preterm neonates hospitalized in the SCBU including those followed up during their first year of life are computerized. The investigators propose to review the clinical charts of the preterm neonates in regards to four main points of care a) feeding, b) infections including early onset of neonatal sepsis, necrotizing enterocolitis and umbilical cord infection, c) body temperature control and d) respiratory distress. This medical charts review will be complemented by i) focus group discussions (FGD) with the medical staff working in the SCBU on the benefits and difficulties in using the existing guidelines for preterm care and by ii) interviews with mothers who delivered a preterm neonate on their experience in caring for their child and the challenges they faced. While performing the retrospective part of the project and after discussing the preliminary findings from the medical staff perception of the existing guidelines, the investigators will evaluate the feasibility to implement some additional recommendations to improve preterm birth outcomes based on recent literature and new protocols for resource-limited settings.

NCT ID: NCT03506841 Completed - Cerebral Palsy Clinical Trials

Cerebrolysin and Neurodevelopment in Preterm Infants

Start date: June 2016
Phase: Phase 1
Study type: Interventional

The overall aim of the study is to assess the effect of Cerebrolysin on physical and mental development of preterm infants by Denver Scale II at different ages of 5, 7 and 12 months

NCT ID: NCT03443297 Not yet recruiting - Preterm Infant Clinical Trials

Early Versus Delayed Feeding in Preterm Growth-Restricted Infants

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The introduction of enteral feeds for preterm, growth restricted infants are often delayed due to concern that early introduction may not be tolerated and may increase the risk of necrotizing enterocolitis. However, prolonged enteral fasting may diminish the functional adaptation of the immature gastrointestinal tract and extend the need for parenteral nutrition with its attendant infectious and metabolic risks. Early introduction of small volumes of milk in the form of Trophic feeding, promote intestinal maturation, may enhance feeding tolerance and decrease the time taken to reach full enteral feeding independently of parenteral nutrition. A Randomized Trial will be carried out over a period of 12 months in Department of Neonatology of BSMMU. Sample size will be 50(25 in each group). Infants with gestation below 35 weeks, birth weight below the 10th percentile for gestational age, will be randomly allocated by web-based randomization to commence enteral feeds "early," whose feeding will be started from 24 to 48 hours of age or "late," whose feeding will be started from 48 to 72 hours of age. Gradually feeding will be increased. Rate of advancement of feeding will be same for both groups. Primary outcomes will be time to achieve full enteral feeding sustained for 72 hours. Statistical analyses will be performed by using Fisher Exact test and by Student's t test for categorical data and quantitative data respectively. Logistic regression analyses will be performed to determine the role of independent variable.