NCT07503457

Brief Summary

Hypothesis H01: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin condition assessment scores. Hypothesis H02: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pH values. Hypothesis H03: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin moisture levels. Hypothesis H04: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on body temperature values. Hypothesis H05: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pulse values. Hypothesis H06: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on saturation values.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 26, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

moisturizing lotioncoconut oilPreterm

Outcome Measures

Primary Outcomes (2)

  • Infant Information and Monitoring Form (Appendix 1):

    The Infant Information Form is an 8-question form prepared by researchers using literature. The form includes information on the baby's demographic characteristics, gender, gestational age at birth and corrected gestational age, mode of delivery, birth weight, head circumference, medical diagnosis, and feeding type. Additionally, a table is included at the bottom of the form for recording the baby's body temperature, heart rate, oxygen saturation, skin moisture, and skin pH before and for 5 days after the procedure.

    five days

  • Neonatal Skin Status Assessment (Appendix 2):

    This scale, developed by Lund and Osborne (2004), is used to assess the skin status of healthy or sick preterm, term, and postterm newborns. The newborn's skin status is scored based on the presence of redness, dryness, and impaired skin integrity/peeling. It is developed as a three-point Likert scale, with each item/finding given a score from 1 to 3. The lowest possible score is 3, and the highest is 9. A total score higher than 3 indicates a risk of impaired skin integrity in the newborn, while a higher score indicates poor skin status. The reliability of the scale has been reported by researchers to be between 0.66 and 0.89.

    five days

Study Arms (2)

Moisturizing Lotion

EXPERIMENTAL

* Intervention Group 1 (Moisturizing Lotion) * The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after application). * Before the application, the parent will be consulted and an "Informed Consent Form" will be completed. * Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care during routine care hours, between 09:00-10:00 in the morning. * The lotion to be used for babies included in the moisturizing lotion group will be kept at the patient's bedside with a barcode label attached to each patient, and a separate sterile container of lotion will be used for each patient. * Before the application, the researcher will wash their hands according to the hospital's procedur

Behavioral: Moisturizing Lotion

Coconut Oil Group

EXPERIMENTAL

Intervention Group 2 (Coconut Oil Group) * The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after the application). * Before the application, the parent will be consulted and an "Informed Consent Form" will be completed. * Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care between 09:00-10:00 in the morning, which are routine care hours. * The oil to be used for babies included in the coconut oil group will be kept at the patient's bedside with a barcode label attached to each patient and will be used in a separate sterile container for each patient. * Before the application, the researcher will wash their hands according to the hospital's procedure.

Behavioral: Oil Application

Interventions

Oil ApplicationBEHAVIORAL

* The researcher will wash their hands again according to the hospital's procedure. * During the application, the baby will first be placed on its back, then on its side and stomach, and the body will be lubricated with coconut oil. * Coconut oil will be applied to the entire body surface except the hands, head, face, and genital area with light touches using the palm of the hand. The application will take approximately 8-10 minutes. The amount of oil to be used in each application will be approximately 3-4 ml/kg.

Coconut Oil Group

The researcher will wash their hands again according to the hospital's procedure. During the application, the baby will first be placed on its back, then on its side and stomach, and the body will be lubricated with moisturizing lotion. Moisturizing Lotion will be applied to the entire body surface except the hands, head, face, and genital area with light touches using the palm of the hand. The application will take approximately 8-10 minutes. The amount of oil to be used in each application will be approximately 3-4 ml/kg.

Moisturizing Lotion

Eligibility Criteria

Age32 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Babies with a gestational age between 320/7 and 376/7 weeks,
  • Babies with a birth weight of 1500 grams or more will be included.

You may not qualify if:

  • are receiving oxygen support at a concentration greater than 23-25% in the incubator,
  • have a major congenital anomaly on the skin surface,
  • have a high infection or risk of infection due to surgery,
  • have a congenital anomaly,
  • have a skin disease/problem covering more than 5% of their body surface will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes Univercity

Aydin, Aydın, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 26, 2026

First Posted

March 31, 2026

Study Start

March 16, 2024

Primary Completion

March 16, 2025

Study Completion

September 16, 2025

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations