Nurse's RoleNCT05812222
The Effect of Early Skin-to-Skin Contact in Normal Births on Suction Sufficiency, Stress and Bilirubin Levels of Newborns
A study testing Skin-to-Skin contact. in people with Nurse's Role and Breastfeeding, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Breastfeeding is one of the most effective ways to ensure a baby's health and survival, and breast milk is the ideal food for babies. It is recommended to start breastfeeding within the first hour of life, following skin-to-skin contact between the mother and the newborn immediately after birth. Read more about this study
- Who is it for?
- Ages 2 minutes to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Breastfeeding
- What is being tested?
- Skin-to-Skin contact.
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 minutes to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For mothers;
- Vaginal delivery planning,
- Be between the ages of 18-45,
- Having a singleton pregnancy
- Having completed the 37th week of gestation,
- Agreeing to participate in the research,
Show all 13Show fewer
- Absence of breastfeeding barriers [without human T-cell lymphotropic virus (HTLV-1), human Immunodeficiency virus (HIV) and active tuberculosis]
- Absence of any known health problems (such as diabetes, gestational diabetes, hypertension, Preeclampsia, renal failure, cardiac problems, psychiatric disorders)
- There was no ABO and Rh incompatibility. For newborns;
- Absence of conditions that prevent sucking such as frenulum or palate problem,
- Absence of any health problems or congenital diseases,
- Apgar Score ≥ 8
- No need for resuscitation after birth.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Breastfeeding is one of the most effective ways to ensure a baby's health and survival, and breast milk is the ideal food for babies. It is recommended to start breastfeeding within the first hour of life, following skin-to-skin contact between the mother and the newborn immediately after birth.
Newborns transition from the dark, narrow and fluid-filled intrauterine environment to the wide, bright, cold and dry extrauterine life during the birth process. Thus, in addition to invasive procedures such as heel lance, vascular access, etc., including the birth process, simple and routine procedures such as separation from its mother in a short time to measure body weight cause stress for the newborn. For this reason, it is recommended that newborns should not be separated from their mothers except for important medical reasons, and that skin-to-skin contact should be initiated as soon as possible after birth so that the newborn can cope with the "birth stress".
Hyperbilirubinemia, as physiological jaundice, usually begins in the first 24-72 hours of life in term newborns. It peaks in the following days and starts to decrease in the following days. Colostrum, which is a natural laxative found in breast milk, facilitates the removal of meconium in the newborn and provides bilirubin excretion with stool. With early skin-to-skin contact between mother and newborn in the first minutes of life after birth; Nurses have a key role in reducing the level of "birth stress" experienced by the newborn and in reducing the severity of hyperbilirubinemia by starting breastfeeding early.
Read the detailed description
The aim of this study; The aim of this study is to examine the effect of early SSC applied after normal delivery on the newborn's sucking efficiency, postnatal stress and bilirubin levels.
Study hypotheses:
H1: Early skin-to-skin contact applied immediately after normal birth has an effect on the sucking efficiency of the newborn.
H2: Normal doğumdan hemen sonra uygulanan erken erken ten tene temasın yenidoğanın stres düzeyine etkisi vardır.
H3: Early skin-to-skin contact applied immediately after normal delivery has an effect on the newborn's bilirubin level.
Type of the research: The research was conducted in a randomized controlled experimental type. Mothers and newborns who met the inclusion criteria were randomly selected by tossing a coin and assigned to the intervention or control groups. The data were collected by the researcher by face-to-face interview method.
- Conditions
- Nurse's Role, Breastfeeding
- Being tested
- Skin-to-Skin contact.
- Keywords
- skin-to-skin contact, normal delivery, stress, breastfeeding, jaundice
- Medical subject headings
- Breast Feeding, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-Skin contact.Behavioural
Skin to skin contact: It is the laying of the newborn in the prone position on the mother's bare chest with only a diaper on.
| Study group | Role | What they receive |
|---|---|---|
| intervention group (skin-to-skin contact group) | Experimental | Skin-to-skin contact: It is the laying of the newborn in the prone position on the mother's bare chest area with only a diaper on.
The stress levels of newborns were determined using the "Neonatal Stress Scale" immediately after birth, under a radiant heater, 5 minutes after SSC administration, and during IM K vit injection while SSC was administered (4 different time periods).
The suction sufficiency of newborns was evaluated by the investigator using the "LATCH Breastfeeding Assessment Tool", 5 minutes after the initiation of early SSC immediately after birth, within the first hour after birth in the maternity ward, and 24 hours after birth. Receives: Behavioral: Skin-to-Skin contact. |
| control group | No intervention | The routine applications of the hospital were applied to the mothers and newborns in the control group. The stress level of newborns was determined immediately after birth, under a radiant heater, and during IM K vit injection (3 different time periods) using the "Neonatal Stress Scale". The suction sufficiency of newborns within the first hour after birth and 24 hours after birth was evaluated by the researcher using the "LATCH Breastfeeding Assessment Tool". |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of early skin-to-skin contact applied immediately after normal delivery on the sucking efficiency of the newborn.
"LATCH Breastfeeding Diagnostic Scale" was used to determine the effect of skin-to-skin contact on sucking efficiency of newborns.
A high score from the scale shows that mothers have good breastfeeding success and newborns have good sucking success.
The name of the "LATCH Breastfeeding Diagnostic Scale" consists of the English initials of the 5 assessment criteria; [L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)].
The sucking efficiency of newborns was evaluated by the researcher with the "LATCH Breastfeeding Diagnostic Scale", 5 minutes after the initiation of early skin-to-skin contact immediately after birth, within the first hour after birth in the maternity ward, and 24 hours after birth.
Measured: through study completion, an average of 1 year
The effect of early skin-to-skin contact applied immediately after normal delivery on the stress level of the newborn.
"Newborn Stress Scale" was used to determine the effect of skin-to-skin contact on after immediately normal delivery stress level of newborns.
A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the stress level of the newborn increases.
The stress levels of newborns were determined using the "Neonatal Stress Scale" immediately after birth, under a radiant heater, 5 minutes after SSC administration, and during IM K vit injection while SSC was administered (4 different time periods).
Measured: through study completion, an average of 1 year
The effect of early skin-to-skin contact applied immediately after normal delivery on the bilirubin level of the newborn.
Starting breastfeeding at least 5 minutes after the skin-to-skin contact application and feeding only with breast milk in the following days.
The determination of feeding only breast milk and formula, body weight and total serum bilirubin level of a newborn brought to the hospital by her parents for routine control on the fifth day of life.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start15 Jun 2020
- Primary completion15 Sep 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group and control group, randomized controlled, experimental study.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812222
- Sponsor's protocol ID
- Nursing123456
- Status last verified
- Mar 2023
- First submitted
- 2 Apr 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Skin-to-Skin Contact in Normal Births on Suction Sufficiency, Stress and Bilirubin Levels of Newborns
- ClinicalTrials.gov ID
- NCT05812222
- Acronym / sponsor ID
- Nursing123456
- Conditions
- Nurse's Role, Breastfeeding
- Keywords
- skin-to-skin contact, normal delivery, stress, breastfeeding, jaundice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breastfeeding is one of the most effective ways to ensure a baby's health and survival, and breast milk is the ideal food for babies. It is recommended to start breastfeeding within the first hour of life, following skin-to-skin contact between the mother and the newborn immediately after birth.
Newborns transition from the dark, narrow and fluid-filled intrauterine environment to the wide, bright, cold and dry extrauterine life during the birth process. Thus, in addition to invasive procedures such as heel lance, vascular access, etc., including the birth process, simple and routine procedures such as separation from its mother in a short time to measure body weight cause stress for the newborn. For this reason, it is recommended that newborns should not be separated from their mothers except for important medical reasons, and that skin-to-skin contact should be initiated as soon as possible after birth so that the newborn can cope with the "birth stress".
Hyperbilirubinemia, as physiological jaundice, usually begins in the first 24-72 hours of life in term newborns. It peaks in the following days and starts to decrease in the following days. Colostrum, which is a natural laxative found in breast milk, facilitates the removal of meconium in the newborn and provides bilirubin excretion with stool. With early skin-to-skin contact between mother and newborn in the first minutes of life after birth; Nurses have a key role in reducing the level of "birth stress" experienced by the newborn and in reducing the severity of hyperbilirubinemia by starting breastfeeding early.
Detailed description
The aim of this study; The aim of this study is to examine the effect of early SSC applied after normal delivery on the newborn's sucking efficiency, postnatal stress and bilirubin levels.
Study hypotheses:
H1: Early skin-to-skin contact applied immediately after normal birth has an effect on the sucking efficiency of the newborn.
H2: Normal doğumdan hemen sonra uygulanan erken erken ten tene temasın yenidoğanın stres düzeyine etkisi vardır.
H3: Early skin-to-skin contact applied immediately after normal delivery has an effect on the newborn's bilirubin level.
Type of the research: The research was conducted in a randomized controlled experimental type. Mothers and newborns who met the inclusion criteria were randomly selected by tossing a coin and assigned to the intervention or control groups. The data were collected by the researcher by face-to-face interview method.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group and control group, randomized controlled, experimental study.
| Arm | Type | Receives |
|---|---|---|
| intervention group (skin-to-skin contact group) | Experimental | Behavioral: Skin-to-Skin contact.Skin-to-skin contact: It is the laying of the newborn in the prone position on the mother's bare chest area with only a diaper on. The stress levels of newborns were determined using the "Neonatal Stress Scale" immediately after birth, under a radiant heater, 5 minutes after SSC administration, and during IM K vit injection while SSC was administered (4 different time periods). The suction sufficiency of newborns was evaluated by the investigator using the "LATCH Breastfeeding Assessment Tool", 5 minutes after the initiation of early SSC immediately after birth, within the first hour after birth in the maternity ward, and 24 hours after birth. |
| control group | No intervention | –The routine applications of the hospital were applied to the mothers and newborns in the control group. The stress level of newborns was determined immediately after birth, under a radiant heater, and during IM K vit injection (3 different time periods) using the "Neonatal Stress Scale". The suction sufficiency of newborns within the first hour after birth and 24 hours after birth was evaluated by the researcher using the "LATCH Breastfeeding Assessment Tool". |
Who may qualify
- Ages
- 2 minutes to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- For mothers;
- Vaginal delivery planning,
- Be between the ages of 18-45,
- Having a singleton pregnancy
- Having completed the 37th week of gestation,
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin-to-Skin contact.Skin to skin contact: It is the laying of the newborn in the prone position on the mother's bare chest with only a diaper on. | Behavioural | intervention group (skin-to-skin contact group) |
Primary outcome
The effect of early skin-to-skin contact applied immediately after normal delivery on the sucking efficiency of the newborn.
Time frame: through study completion, an average of 1 year
"LATCH Breastfeeding Diagnostic Scale" was used to determine the effect of skin-to-skin contact on sucking efficiency of newborns. A high score from the scale shows that mothers have good breastfeeding success and newborns have good sucking success. The name of the "LATCH Breastfeeding Diagnostic Scale" consists of the English initials of the 5 assessment criteria; [L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)]. The sucking efficiency of newborns was evaluated by the researcher with the "LATCH Breastfeeding Diagnostic Scale", 5 minutes after the initiation of early skin-to-skin contact immediately after birth, within the first hour after birth in the maternity ward, and 24 hours after birth.
The effect of early skin-to-skin contact applied immediately after normal delivery on the stress level of the newborn.
Time frame: through study completion, an average of 1 year
"Newborn Stress Scale" was used to determine the effect of skin-to-skin contact on after immediately normal delivery stress level of newborns. A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the stress level of the newborn increases. The stress levels of newborns were determined using the "Neonatal Stress Scale" immediately after birth, under a radiant heater, 5 minutes after SSC administration, and during IM K vit injection while SSC was administered (4 different time periods).
The effect of early skin-to-skin contact applied immediately after normal delivery on the bilirubin level of the newborn.
Time frame: through study completion, an average of 1 year
Starting breastfeeding at least 5 minutes after the skin-to-skin contact application and feeding only with breast milk in the following days. The determination of feeding only breast milk and formula, body weight and total serum bilirubin level of a newborn brought to the hospital by her parents for routine control on the fifth day of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin-to-Skin contact. in people with Nurse's Role and Breastfeeding, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of early skin-to-skin contact applied immediately after normal delivery on the sucking efficiency of the newborn. (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.