PrematureTR-SSCinNICUNCT06672913
Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study
A study testing skin to skin contact care in people with Premature and Skin to Skin Contact, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care in NICU, initiated early and applied regularly, on recieving exclusive mothers' milk at discharge and clinical… Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Premature, Skin to Skin Contact, Breast Feeding
- What is being tested?
- skin to skin contact care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants born at gestational age ≤ 32 weeks
Who cannot join
- Death before NICU discharge
- Abdominal wall defects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University
Ankara
Sezin Unal, 0090532, sezinunal@gmail.com
Canan SEREN, MD
About this study
This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care in NICU, initiated early and applied regularly, on recieving exclusive mothers' milk at discharge and clinical outcomes for preterm infants born ≤ 32 weeks of gestation.
- Primary Objective: To evaluate the rate of receiving exclusive mothers' milk at discharge for infants born ≤ 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.
- Secondary Objective: To evaluate the rates of neonatal sepsis, intraventricular hemorrhage, and necrotizing enterocolitis (stage 2 and above) as well as the length of hospital stay for infants born at or below 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.
Read the detailed description
- Introduction: Throughout the historical evolution of the field of neonatology, negative consequences of newborns being separated from their families for extended periods while in neonatal intensive care units (NICUs) have been observed. In 1978, the concept of "Skin-to-skin care: Kangaroo Mother Care" was introduced. This model has been recommended by the World Health Organization to replace incubators and radiant warmer technologies in developing and least developed countries, where the capacity of NICUs is very limited. Additionally, in developed countries, where newborn health indicators are optimal, family-centered care and family-integrated care approaches have been used as crucial components to maintain the bond between mothers-and even families-with patients requiring NICU care and premature newborns. Canada in North America and Scandinavian countries in Europe are pioneers of this approach. In developed countries that have adopted this model, regardless of how small, premature, or ill the newborn is, their medical needs are met from birth while ensuring skin-to-skin care with their mother or father. In today's changing architecture of NICUs, care and treatment are conducted in "personalized neonatal intensive care areas for families," with the participation of families. Skin-to-skin care has been shown to be effective in improving breastfeeding rates, enhancing bonding, better physiological stability, reducing stress levels, shortening hospital stays, decreasing the risk of infections, lowering rates of intraventricular hemorrhage, and improving weight gain and parental confidence. Additionally, it has been shown to be most effective when skin-to-skin care is applied for more than one hour in a single session and for more than eight hours in a day. This can be best assured if a protocol exists in the units.
- Objective: This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care application, which is initiated early and applied regularly, on clinical outcomes for preterm infants born at less than 32 weeks of gestation.
- Primary Objective: To evaluate the rate of receiving exclusive mothers' milk at discharge for infants born ≤ 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.
- Secondary Objective: To evaluate the rates of neonatal sepsis, intraventricular hemorrhage, and necrotizing enterocolitis (stage 2 and above) as well as the length of hospital stay for infants born at or below 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.
- Method: Eight training institutions (hospitals) from different geographical regions of Turkiye will be selected. Once the chair of the selected NICUs express their consent to participate, detailed information about the project will be provided to them. The training program developed regarding the skin-to-skin care approach will be delivered in a face-to-face format on a full training day for the responsible physicians and nursing staff working in the units. The theoretical lesson program will consist of three 45-minute lessons (history, standard skin-to-skin care application, skin-to-skin care application for at-risk infants). Practical lessons will be conducted in pairs using a realistic scenario with models. Following the theoretical and practical lessons, the aim is to implement skin-to-skin care based on a standardized protocol for at least one hour per each session, initiated early and regularly.
- The skin-to-skin care application proposed by the Turkish Neonatology Association is as follows:
- Duration: At least one hour per session ii. Time to initiate first skin-to-skin care: GA: < 28 weeks: After the 72nd hour GA: 28 - 32 weeks: As soon as stabilization is ensured iii. Criteria to accepted as stabilization: Absence of hypothermia Normal arterial tension with or without inotropic treatment Vital signs stable or easily normalized after nursing care Absence of frequent (>3/hour) and profound (any apnea requiring positive pressure ventilation in the last three hours) apnea
- Data Recording: Feeding details at discharge (Exclusive mothers'milk, ≥ 50% mothers' milk, < 50% mothers' milk, Formula) and data regarding outcomes (sepsis, intraventricular hemorrhage, necrotizing enterocolitis, duration of hospitalization) will be recorded for patients in the pre-education and post-education groups in each unit. The pre-education group includes infants discharged from the units in the two months prior to training, while the post-education group includes infants discharged from the units between the fourth and sixth months after training. Data collected before and after the intervention will be analyzed.
- Sample Size: To determine the sample size, a power analysis was conducted using the OpenEpi program. Assuming a 95% confidence level (1-α), an 80% test power (1-β), and an expected effect size of d=0.25, it was determined that at least 59 samples are required in each group.
- Conditions
- Premature, Skin to Skin Contact, Breast Feeding, Necrotizing Enterocolitis, Retinopathy of Prematurity
- Being tested
- skin to skin contact care
- Keywords
- Premature, Skin to skin contact, Breast Feeding, Necrotizing Enterocolitis, Retinopathy of Prematurity
- Medical subject headings
- Premature Birth, Breast Feeding, Enterocolitis, Necrotizing, Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin to skin contact careBehavioural
Early and regular skin to skin contact in NICU GA: < 28 weeks: After the 72nd hour GA: 28 - 32 weeks: As soon as stabilization is ensured
| Study group | Role | What they receive |
|---|---|---|
| Pre education | No intervention | The infants born at less than 32 weeks and discharged from the units in the last two months before training. |
| Post education | Active comparator | The infants born at less than 32 weeks and discharged between four to six months after training Receives: Behavioral: skin to skin contact care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' Milk at Discharge
Number of infants receiving Exclusive Mothers' Milk at Discharge
Measured: Through study completion, an average of 3 months, at the time of discharge
Secondary outcomes (5)
Intraventricular hemorrhage
Number of infants with intraventricular hemorrhage diagnosed by cranial ultrasound
Measured: Through study completion, an average of 3 months, at the time of discharge
Necrotizing enterocolitis (stage 2 and above)
Number of infants with necrotizing enterocolitis (stage 2 and above) according to Bell's criteria
Measured: Through study completion, an average of 3 months, at the time of discharge
Early neonatal sepsis
Number of infants with sepsis within first three days of admission; culture positive or clinical
Measured: Through study completion, an average of 3 months, at the time of discharge
Late neonatal sepsis
Number of infants with sepsis after the third day of admission; culture positive or clinical
Measured: Through study completion, an average of 3 months, at the time of discharge
Length of hospital stay
Total length of hospital stay
Measured: Through study completion, an average of 3 months, at the time of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Sep 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-center, prospective pre and post training interventional clinical study. The effect of a standardized skin-to-skin contact application, which is initiated early and applied regularly, on clinical outcomes for preterm infants born at less than 32 weeks of gestation will be investigated. Intervention: Teoritical and practical education on skin to skin contact to ensure the application of Turkish Neonatal Society skin to skin contact protocol.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University, Gazi University, Hacettepe University, Marmara University, Umraniye Education and Research Hospital, Trakya University, Ege University, Ondokuz Mayıs University, Cukurova University, Sanliurfa Harran University, Cumhuriyet University, Uludag University, Kocaeli University, Aydin Adnan Menderes University, Konya City Hospital, Baskent University
- Responsible party
- Principal investigator, Sezin Unal, Baskent University Ankara Hospital
- Investigators
- Esin Koc, Prof, MD, Study chair, Gazi UniversitySaadet Arsan, Prof, MD, Study director, Ankara UniversityHülya Bilgen, Prof, MD, Study director, Marmara Universityİlke Mungan Akın, Prof, MD, Study director, Umraniye Teaching and Research HospitalBetül Acunaş, Prof, MD, Study director, Trakya UniversityMehmet Yalaz, Prof, MD, Study director, Ege UniversitySezin Unal, Prof, MD, Study director, Baskent UniversitySule Yigit, Prof, MD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672913
- Sponsor's protocol ID
- TR-SSCinNICU
- Acronym
- TR-SSCinNICU
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No