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

Official title

The Effect of Kangaroo Care and Maternal Voice on Comfort, Anthropometric Measurements, and Transition to Oral Feeding in Preterm Infants

Overview

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.

Detailed description

After obtaining ethical approval for the study, all infants with a gestational age between 30 and 34 weeks in the Neonatal Clinic will be evaluated. After the infants are assigned to groups, the data collection phase will begin.

Before data collection, the researcher will provide necessary information about the study to the families of eligible newborns and answer their questions. Infants whose parents give written consent to participate will be included in the study. Information on the newborn and parent introductory information form will be recorded by the researcher. All procedures will be conducted between 08:00 and 16:00.

\*\*Group 1: Infants Receiving Kangaroo Care (Kangaroo Care + Mother's Voice + Fetal Position Group):\*\* Infants in this group, once clinically stable, will receive kangaroo care with their mothers for one hour immediately after enteral feeding at least five days a week until they transition to full oral feeding. During the first 15 minutes of skin-to-skin contact, the mother will read a story to the baby. After kangaroo care, infants will be placed in the incubator and positioned in the lateral fetal position for half an hour. During this process, interventions will be minimized unless necessary.

Until full oral feeding is achieved, comfort will be assessed using the Neonatal Comfort Behavior Scale at least five days a week, once daily: before feeding, immediately before ending kangaroo care (at 60 minutes), and 30 minutes after fetal positioning (at 90 minutes).

On the mornings of kangaroo care days, before feeding, the infant's growth will be evaluated: the infant will be weighed naked using a digital baby scale sensitive to ±10 grams; length and head circumference will be measured with a non-stretchable measuring tape and recorded.

\*\*Group 2: Control Group (Fetal Position Group):\*\* Infants in this group, whose mothers are not able to attend, will be placed in the incubator in the lateral fetal position for one and a half hours immediately after enteral feeding at least five days a week until full oral feeding is achieved.

The same measurements performed in the Kangaroo Care Group will be conducted and recorded for infants in this group until full oral feeding transition.

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
• 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

Primary outcome measures

• Comfort [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.]
• Transition to Oral Feeding [Time frame: From the date of study enrollment until the date of transition to full oral feeding, assessed for up to 8 weeks.]

Secondary outcome measures (1)

• Anthropometric measurements [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.]

Eligibility criteria

Inclusion criteria

• 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.
• Infants whose mothers agree to engage in skin-to-skin contact for 1 hour, five sessions per week, with auditory stimulation (storytelling) for 15 minutes will be included in the study.
• Infants whose mothers cannot participate in the study (due to health issues or other reasons) or refuse kangaroo care will be placed in the control group, where routine service care will be applied.

Exclusion criteria

• Presence of a congenital anomaly or genetic disease.
• Requirement of ventilator support.
• Infants receiving antibiotics for sepsis or suspected sepsis.
• Administration of sedative treatment.
• Having an intracranial hemorrhage greater than grade II.
• The mother having a physical condition that prevents skin-to-skin contact.
• The mother using substances or alcohol.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Fenerbahce University — Istanbul

Identifiers

NCT: NCT07045402 · 4507

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗