Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants
NCT07045402 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2025-09-04
Summary
This randomized controlled study aims to evaluate the effects of kangaroo care combined with maternal voice and fetal positioning on the comfort, growth, and transition to full oral feeding in preterm infants aged 30 to 34 weeks gestation. After ethical approval, eligible infants in the neonatal clinic will be randomly assigned to either the intervention group receiving kangaroo care, maternal voice, and fetal positioning, or a control group receiving only fetal positioning in the incubator. The intervention involves daily one-hour kangaroo care sessions with maternal storytelling, followed by positioning in the lateral fetal posture, continuing at least five days per week until infants achieve full oral feeding. Infant comfort will be assessed regularly using the Neonatal Comfort Behavior Scale before feeding, immediately after kangaroo care, and after fetal positioning. Growth parameters, including weight, length, and head circumference, will be measured and recorded on kangaroo care days. The control group will receive routine fetal positioning without kangaroo care, with identical measurements taken. The study aims to determine whether kangaroo care combined with maternal voice and fetal positioning improves infant comfort, supports growth, and facilitates the transition to full oral feeding in preterm newborns.
Conditions
- Infant, Premature
- Kangaroo Mother Care
- Comfort
- Feeding
- Oral Feeding Performance
- Facilitated Tucking
Interventions
- OTHER
-
Kangaroo Care + Maternal Voice + Fetal Position Group
After ethical approval, all infants with a gestational age between 30-34 weeks in Neonatal Intensive Care Unit will be assessed. Parents of eligible infants will be informed about the study and asked to provide written consent. The infants will then be assigned to one of two groups: kangaroo care + mother's voice + fetal position (n=34) or fetal position only (n=34). In the first group, after tube feeding, infants will receive one hour of kangaroo care with the mother, including reading a story for the first 15 minutes. After finishing kangaroo care,they will then be placed in a fetal position in an incubator for 30 minutes. Comfort levels, weight, length, and head circumference will be measured daily until oral feeding begins, and the impact of kangaroo care and the mother's voice on the transition to full oral feeding will be assessed. All procedures will occur between 08:00 and 16:00.
- OTHER
-
control group
After ethical approval, all infants with a gestational age between 30-34 weeks in the Neonatal Intensıve Care Unit will be assessed. Parents of eligible infants will be informed about the study and asked to provide written consent. If infant is in the fetal position group, after being fed by a oral gastric tube, they will be placed in an incubator and positioned in a fetal position similar to that in the womb for one and a half hours. During all these procedures, infant's comfort levels will be assessed using a scale (form), and their weight, length, and head circumference will be measured every morning until they begin oral feeding. Additionally, the effect of the fetal position on infant's transition to full oral feeding will be evaluated.All procedures will take place between 08:00 and 16:00.
Sponsors & Collaborators
-
Fenerbahce University
lead OTHER
Principal Investigators
-
Canan GENÇ, Ph.D student · Fenerbahce University
-
Duygu Gözen, Ph.D · Koç University
-
NEGARIN Akbari, Ph.D · Fenerbahce University
-
Melek Selalmaz, Ms.c · ŞİŞLİ HAMİDİYE ETFAL TRAINING AND RESEARCH HOSPITAL
-
Ali Bulbul, Doctor · ŞİŞLİ HAMİDİYE ETFAL TRAINING AND RESEARCH HOSPITAL
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Weeks
- Max Age
- 34 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-02-10
- Primary Completion
- 2026-02-10
- Completion
- 2026-03-10
Countries
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Skin-to-skin Contact Between Premature Infant and Mother
NCT06380231 ·Status: COMPLETED ·Phase: NA
-
Hammock Position and Kangaroo Care
NCT06436404 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Cerebral Oxygenation Results in Premature Infant
NCT04725435 ·Status: COMPLETED ·Phase: NA
-
Extruded the effectıveness of Prone posıtıon ın ınfants evaluatıon
NCT06493058 ·Status: COMPLETED ·Phase: NA
-
Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants
NCT06707376 ·Status: COMPLETED ·Phase: NA
-
Comparison Three Methods on Endotracheal Aspiration in Preterm Infants
NCT05434364 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies
NCT06144450 ·Status: COMPLETED ·Phase: NA
-
Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns
NCT05036603 ·Status: COMPLETED ·Phase: NA
-
Suction and Swalloing Exercises for Premature Babies
NCT06371443 ·Status: COMPLETED ·Phase: NA
-
The Effect of Diaper Change Position on Preterm Infants
NCT04528602 ·Status: COMPLETED ·Phase: NA
-
Comparison of the Results of Premature Babies Started Complementary Feeding
NCT04499430 ·Status: UNKNOWN
-
The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes
NCT05807191 ·Status: COMPLETED ·Phase: NA
-
Effects of Early Physiotherapy Program on the Infants in NICU
NCT07201792 ·Status: RECRUITING ·Phase: NA
-
Effect of "Kangaroo Mother Care" on Premature Infants Physiological Outcomes
NCT02919540 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.
NCT03990116 ·Status: COMPLETED ·Phase: NA
-
The Effect of Positioning With Material and Hand-Face Maneuver
NCT06136130 ·Status: COMPLETED ·Phase: NA
-
Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics
NCT02962609 ·Status: COMPLETED ·Phase: NA
-
Effects of Intermittent Feeding Methods With Nasogastric and Orogastric Tubes in Preterm Infants
NCT06765720 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Lung Ultrasound-Guided Positioning Strategy for the Prevention of Ventilator-Associated Pneumonia in Neonates
NCT07254507 ·Status: COMPLETED ·Phase: NA
-
Effect of Cradle Position During Orogastric Tube Feeding on Comfort, Physiological Parameters and Vomiting
NCT06759285 ·Status: COMPLETED ·Phase: NA
-
Comparison of The Effects of Initial Oral Feeding by Cup and Bottle-Feeding of Preterm Infants
NCT05683210 ·Status: COMPLETED ·Phase: NA
-
The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.
NCT03631264 ·Status: UNKNOWN ·Phase: NA
-
Kangaroo Care and Premature Infant Sleep
NCT02473055 ·Status: COMPLETED ·Phase: NA
-
Effects of Fetal Positioning During Venipuncture
NCT06173622 ·Status: COMPLETED ·Phase: NA
-
Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation
NCT03895242 ·Status: COMPLETED ·Phase: NA