Effect of Developmental Care on Comfort, Growth, and Oral Feeding Transition in Preterm Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-34
SponsorFenerbahce University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Infants with a gestational age between 30-34 weeks.

The mother's ability to read and write.

The infant must be fully enterally fed at the time of enrollment in the study.

Infants who are being fed via orogastric tube at the time of enrollment.

Disqualifiers

Presence of a congenital anomaly or genetic disease.

Requirement of ventilator support.

Infants receiving antibiotics for sepsis or suspected sepsis.

Administration of sedative treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kangaroo Care + Maternal Voice + Fetal Position Group

    Other intervention

    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.

  • control group

    Other intervention

    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.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Kangaroo Care + Maternal Voice + Fetal Position GroupExperimental treatment 1 intervention
Group B: Control Group: (Fetal Position group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comfort

The scale is a Likert-type tool developed to assess the sedation and comfort needs, as well as pain and distress levels, of newborns monitored in intensive care units. The Numeric Rating Scales are based on the caregiver nurse's observations. Each item on the scale is scored from 1 to 5, and the total score is used for evaluation. The minimum possible score on the Neonatal Comfort Behavior Scale is 6, and the maximum is 30. A total score between 9 and 13 indicates that the infant is comfortable, while a score between 14 and 30 suggests that the infant is experiencing pain or distress, is uncomfortable, and requires comfort-providing interventions.

Time frame
Until full oral feeding is achieved, evaluations will be conducted at least five days a week, once a day, at the following time points: before feeding, immediately before ending kangaroo care (at the 60th minute), and 30 minutes after placing the infant.
2

Transition to Oral Feeding

The time from the infant's inclusion in the study until the transition to full oral feeding will be evaluated.

Time frame
From the date of study enrollment until the date of transition to full oral feeding, assessed for up to 8 weeks.

Secondary outcomes

1

Anthropometric measurements

On the mornings of the days when kangaroo care will be applied, the infant's growth and development will be assessed before feeding. The baby will be weighed naked using a digital baby scale with ±10 grams sensitivity. Body length and head circumference will be measured using a non-flexible measuring tape.

Time frame
From the first day of the intervention until the end of the 4-week study period, measurements will be taken at 9:00 a.m. prior to feeding on each day kangaroo care is provided.

Other outcomes

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