Recruiting NA Infant, Premature

New treatment option for Infant, Premature

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

ClinicalTrials.gov ID: NCT07045402

What this study is testing

What it's testing
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.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 30 to 34. Healthy volunteers may be eligible.

You may be able to join if

  • 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...

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Istanbul, Turkey (Türkiye)

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 30 weeks to 34 weeks. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.