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Feeding Disorder Neonatal clinical trials

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NCT ID: NCT06246032 Active, not recruiting - Preterm Clinical Trials

Impact of Modified Feeding Protocol on Neonatal Outcomes

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

The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg. The main questions it aims to answer are: - Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay? - Is Modified feeding protocol feasible, efficient, and safe in preterm infants? Participants will undergo the modified feeding protocol since birth until discharge.

NCT ID: NCT06118697 Not yet recruiting - Clinical trials for Feeding Disorder Neonatal

Feasibility of Aerodigestive Stimulation Therapy Trial

FAST
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are: - To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding. - To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding. Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.

NCT ID: NCT05802095 Not yet recruiting - Breastfeeding Clinical Trials

Effect of Supplemental Feeding Tube Devices in Breastfeeding Success and Mother's Breastfeeding Self-Efficacy

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

The research will be carried out as a randomized controlled experimental design to evaluate the effectiveness of the breastfeeding support system to increase sucking success in premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers. In the study, the experimental and control groups will be determined by randomization of premature babies hospitalized in the NICU. While the babies in the control group will be fed with the routine feeding method (bottle) of the NICU, the babies in the experimental group will be fed with the breastfeeding support system by their mother. Research data will be collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.

NCT ID: NCT05604846 Recruiting - Death Clinical Trials

Probiotic Supplementation in Extremely Preterm Infants in Scandinavia

PEPS
Start date: December 16, 2022
Phase: N/A
Study type: Interventional

The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely preterm (EPT) infants born before gestational week 28. P: The study population include EPT infants (n= 1620) born at six tertiary neonatal units in Sweden and four units in Denmark. I: This is a double-blinded multicenter randomized controlled trial where infants in the intervention group will as soon as they tolerate 3 mL breastmilk per feed receive a probiotic combination of Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus diluted in 3 mL breastmilk and given once daily until gestational week 34. C: The control group will receive 3 mL breastmilk without probiotic supplementation (blinded) daily. O: Primary outcome variables is a composite endpoint of incidence of NEC and mortality. Secondary outcomes include incidence of sepsis, duration of hospital stay, use of antibiotics, feeding tolerance, growth, and body composition after hospital discharge. Patient benefit: To provide evidence on the usage of probiotics among EPT infants that are not currently covered by clinical recommendations. As EPT infants have the highest risk for NEC and mortality our results have the potential to change current recommendations and improve patient outcomes, decrease mortality, shorten hospitalization, and decrease overall health-care costs.

NCT ID: NCT05525091 Recruiting - Feeding Patterns Clinical Trials

Neoneur Feeding System Functionality in the Clinic

NN200
Start date: July 14, 2022
Phase: N/A
Study type: Interventional

Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial

NCT ID: NCT04325308 Active, not recruiting - Clinical trials for Microbial Colonization

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Start date: August 13, 2020
Phase: N/A
Study type: Interventional

The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.

NCT ID: NCT04290338 Not yet recruiting - Clinical trials for Feeding Disorder Neonatal

Effects of PIOMI on Oral Feeding of the Premature Infants

PIOMI2020
Start date: March 2020
Phase: N/A
Study type: Interventional

Randomized controlled clinical trial aimed at evaluating the effects of the "Premature infant oral motor intervention" method on the oral feeding skills of the premature infants.

NCT ID: NCT04282655 Completed - Weight Gain Clinical Trials

Effect of Milk Warming on the Very Low Birth Weight Infant

VLBW
Start date: September 2, 2016
Phase: N/A
Study type: Interventional

This study will compare if using a continuous milk warmer to warm breast milk compared to the standard method of warming breast milk in a hot water bath improves weight gain and feeding tolerance in infants born at 32 weeks gestation or less over a ten-day period. The standard method does not keep the breast milk at a consistent temperature during the feeding. A continuous milk warmer maintains the breast milk at body temperature throughout the feeding. It is unknown which method improves weight gain and feeding tolerance in very low birth weight infants.

NCT ID: NCT04246333 Recruiting - Premature Birth Clinical Trials

Duodenal Feeds in Very Low Birth Weight Infants

Start date: August 7, 2020
Phase: N/A
Study type: Interventional

Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.

NCT ID: NCT04062851 Completed - Preterm Infant Clinical Trials

Routine Versus no Assessment of Gastric Residual Volumes in Preterm Infants

Start date: May 3, 2019
Phase: N/A
Study type: Interventional

The practice of checking gastric residuals is not evidence based. The amount of gastric residual volume (GRV) does not correlate with either feeding intolerance or development of NEC. We hypothesize that not monitoring GRV in infants with birth weights < 1,250 g, and who are being fed intermittently by gastric tube, will result in earlier attainment of full feeding. This is an unblinded randomized controlled trial where GRV will not be checked routinely in the intervention group.