Hyperbilirubinemia, NeonatalBreastfeedingNCT04445675
The Effect of Breastfeeding Support on Hospitalization Due to Jaundice
A study testing Support for breastfeeding and the feeding of infants' with breast milk in people with Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Neonatal jaundice is the most common reason for rehospitalization after postnatal discharge. Jaundice due to breastfeeding failure is an important subtype of pathological neonatal jaundice. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- What is being tested?
- Support for breastfeeding and the feeding of infants' with breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Jan 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Normal delivery of the mother
- Mother being primiparous
- Newborn being >38 GW
- Having no multiple infants
- Absence of congenital anomaly (craniofacial abnormality such as cleft palate, cleft lip, paralysis of facial muscles) in the newborn
- No blood incompatibility between mother and father
Show all 13Show fewer
- Exclusive breastfeeding of the newborn
- Non-contraindication of the mother's milk to her infant
- Absence of the mother's diagnosed psychiatric story
- Mother's openness to communication and cooperation
- Mother's volunteering to participate in the study
- Mother being literate
- Mother's age above 18 years
Who cannot join
- • Separation of the mother and the infant due to any situation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Support Provided for Breastfeeding and the Feeding of Infants' With Breast Milk on Hospitalization Due to Jaundice
Neonatal jaundice is the most common reason for rehospitalization after postnatal discharge. Jaundice due to breastfeeding failure is an important subtype of pathological neonatal jaundice. Typically, it occurs with lactation failure, which results in dehydration (reducing urine output), significant weight loss (>10% of birth weight) and sometimes hypernatremia, during the first postnatal week. Jaundice caused by breastfeeding failure is observed in one third (31.8%) of total cases of pathological neonatal jaundice requiring rehospitalization. Jaundice lasts for an average of 6.8 days and the length of hospital stay takes up to 3 days. Jaundice due to breastfeeding failure requires focused efforts for a program structured with breastfeeding education and special breastfeeding support. This support causes the role of nurses to become even more important. The aim of this study is to investigate the effect of support provided for breastfeeding and the feeding of infants' with breast milk on hospitalization due to jaundice.
Research Hypotheses:
Read more
H0: The support provided for breastfeeding and the feeding of infants' with breast milk has no effect on hospitalization due to jaundice.
H1: The support provided for breastfeeding and the feeding of infants' with breast milk affects the consequences of hospitalization due to jaundice.
Read the detailed description
Background: Neonatal jaundice is a condition that is accompanied by hyperbilirubinemia. Almost all newborns (60% term and 80% preterm) have more than 5mg/dl of bilirubin during the first week of life, and approximately 6% of term infants may have levels exceeding 15 mg/dl (Young Infants Clinical Signs Study Group, 2008). It is one of the most common causes of morbidity during the first week of life. High serum bilirubin level leads to serious consequences and neurologic disorders in some of the infants with jaundice. 5-10% of these newborns have clinically important neonatal jaundice that requires treatment and care to prevent neurotoxicity and reduce serum bilirubin level (Madan, Mac Mohan, Stevenson, 2005). Recent studies in the literature have shown that there is a strong relationship between hyperbilirubinemia and breastfeeding (Garg, 2018; Flaherman 2017). In a study, it was indicated that breastfed infants had lower bilirubin levels on postnatal day 3 compared to infants fed with infant formula. The problem of jaundice that increases due to insufficient intake of breast milk/breastfeeding is usually underestimated, an exaggerated physiological jaundice treatment is often administered (symptomatically phototherapy), and breastfeeding problems are neglected (Stark, Bhutani 2016). Therefore, while the infant and the mother try to adapt to each other for successful breastfeeding, the treatment process increases breastfeeding difficulties and failure during the first postnatal week. The role and counseling of the infant's nurse are of great importance in breastfeeding of the newborn and the education of the family in neonatal jaundice. The first postnatal hours and days are the most critical times for ensuring the success of breastfeeding. Jaundice due to breastfeeding failure requires focused efforts for a program structured with breastfeeding education and special breastfeeding support. This support causes the role of nurses to become even more important.
Method: This is a randomized controlled experimental study. The data of the study will be collected from primiparous mothers who had normal delivery in the Gynecology and Obstetrics Department in Sakarya Maternity and Children's Hospital Campus affiliated to the Ministry of Health Sakarya University Training and Research Hospital between 01.08.2020-01.01.2021 and their infants until January 2021. The sample of the study was calculated in accordance with the intervention group selection criteria and by performing power analysis. Power analysis was performed using G*Power (v3.1.7) program in order to determine sample size. The effect range value was taken as 0.70 as the method used in cases where it is unknown how many units difference is significant between the groups. In cases where Type 1 error probability (α) was 0.05 (at a confidence level of 95%), at a power level of 80% and the effect range was 0.70, the study was planned with a total of 68 mothers, including 34 mothers women for each group. The mothers to be allocated to the study and control groups will be ensured to have similarity in terms of three factors (age, educational status, gender of the infants). The individuals will be allocated into groups by simple random sampling. The sample of the study will be randomly allocated into two groups: the intervention group will be supported for breastfeeding and the feeding of infants' with breast milk, and the other group, which was the control group, will be followed in routine care of the service. Single-blind (researchers are not blind) randomization will be provided since the mothers will be provided with support for breastfeeding and the feeding of infants' with breast milk by the researchers. The statistician was also blinded for the data analysis purpose. With regard to data collection tools, the "Mother Introductory Information Form" including socio-demographic characteristics of the family, the "Newborn Introductory Information Form" including characteristic features of the infants, the "Infant Nutrition Follow-up Form" for the follow-up of breast milk milked after breastfeeding, and the "Jaundice Follow-up Form" including the follow-up of infants who are hospitalized due to jaundice before/after discharge will be used. Mothers in the experimental group will be provided with breastfeeding support, and if required, the mother's both breasts will be milked by hand and the resulting breast milk will be collected in a container. After milking, the milk will be given to the infant with the help of a teaspoon. This practice will be shown to the mother and will be performed after each feeding during the hospital stay. Mothers will be told to perform this practice at home until the infant sucks effectively and strongly, and families will be called by phone daily. No intervention will be made to the control group. Bilirubin measurements of both groups will be performed with a transcutaneous bilirubin meter both before discharge from the hospital and at the end of week 1, and the values will be recorded. At the same time, the conditions of rehospitalization due to jaundice at the end of week 1 will be recorded. In the evaluation of data, statistical analyses will be performed using the SPSS package program. The Kolmogorov-Smirnov (K-S) test will be used for normality. In order to determine whether there is a difference in the dependent variables compared to independent variables, the independent group t-test will be used if the distribution is normal in independent variables with two options, and Mann Whitney-U test will be used if distribution is not normal. The results will be evaluated at a confidence level of 95% and at a level of significance of p<0.05.
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- Being tested
- Support for breastfeeding and the feeding of infants' with breast milk
- Keywords
- Newborn, Hyperbilirubinemia, Breastfeeding support, Nurse
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support for breastfeeding and the feeding of infants' with breast milkOther
The content of the support for breastfeeding and the feeding of infants' with breast milk consists of the titles of the importance of breastfeeding and breast milk, the effect of breast milk on preventing jaundice, the importance of early start of breastfeeding, breastfeeding techniques and positions in infants, milking, storage and later use of milk, increasing the quantity and quality of milk, and nutrition of the mother during breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The support for breastfeeding and the feeding of infants' with breast milk will be conducted in one stage for the experimental group. (1) breastfeeding support education. The content of the support for breastfeeding and the feeding of infants' with breast milk and the materials used were determined by the researchers in accordance with the literature. The content of the support for breastfeeding and the feeding of infants' with breast milk consists of the titles of the importance of breastfeeding and breast milk, the effect of breast milk on preventing jaundice, the importance of early start of breastfeeding, breastfeeding techniques and positions in infants, milking, storage and later use of milk, increasing the quantity and quality of milk, and nutrition of the mother during breastfeeding. Breastfeeding support will be provided in the postpartum service and lactation outpatient clinic of the relevant hospital. Receives: Other: Support for breastfeeding and the feeding of infants' with breast milk |
| Control Groups | No intervention | The infants in the control group will be followed up in routine service. No intervention will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of bilirubin with a Transcutaneous bilirubinometer in the study and control groups
The device is suitable for use in newborn infants. The device measures by reader head's contact with the infant's forehead and by preventing user's possibility of making a mistake. The device shows the result on the LCD screen after 5 separate readings or has single and average measurement system. A value of above 5-7 mg/dl in the newborn is hyperbilirubinemia.
Measured: Change between the 1 day of discharge from hospital and the 7th day
Secondary outcomes (1)
hospitalization due to jaundice in the study and control groups
The study and control groups will be checked to see if they are hospitalized due to jaundice. Jaundice Follow-up Form created by the researchers includes questions status do hospitalizations
Measured: 7 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Karakaya Suzan, Sakarya University
- Investigators
- Pinar Tabakoglu, MSc, Principal investigator, Sakarya UniversityVedat Cinar, MSc, Principal investigator, Sakarya Universitynursan cinar, professor, Study director, Sakarya UniversitySultan Peksen, Principal investigator, Sakarya University Training and Research Hospitalözge Karakaya Suzan, MSc, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445675
- Sponsor's protocol ID
- Ozge
- Acronym
- Breastfeeding
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: typically after the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Support Provided for Breastfeeding and the Feeding of Infants' With Breast Milk on Hospitalization Due to Jaundice
- ClinicalTrials.gov ID
- NCT04445675
- Acronym / sponsor ID
- Breastfeeding / Ozge
- Conditions
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
- Keywords
- Newborn, Hyperbilirubinemia, Breastfeeding support, Nurse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 24 Jun 2020 (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.
Neonatal jaundice is the most common reason for rehospitalization after postnatal discharge. Jaundice due to breastfeeding failure is an important subtype of pathological neonatal jaundice. Typically, it occurs with lactation failure, which results in dehydration (reducing urine output), significant weight loss (>10% of birth weight) and sometimes hypernatremia, during the first postnatal week. Jaundice caused by breastfeeding failure is observed in one third (31.8%) of total cases of pathological neonatal jaundice requiring rehospitalization. Jaundice lasts for an average of 6.8 days and the length of hospital stay takes up to 3 days. Jaundice due to breastfeeding failure requires focused efforts for a program structured with breastfeeding education and special breastfeeding support. This support causes the role of nurses to become even more important. The aim of this study is to investigate the effect of support provided for breastfeeding and the feeding of infants' with breast milk on hospitalization due to jaundice.
Research Hypotheses:
H0: The support provided for breastfeeding and the feeding of infants' with breast milk has no effect on hospitalization due to jaundice.
H1: The support provided for breastfeeding and the feeding of infants' with breast milk affects the consequences of hospitalization due to jaundice.
Detailed description
Background: Neonatal jaundice is a condition that is accompanied by hyperbilirubinemia. Almost all newborns (60% term and 80% preterm) have more than 5mg/dl of bilirubin during the first week of life, and approximately 6% of term infants may have levels exceeding 15 mg/dl (Young Infants Clinical Signs Study Group, 2008). It is one of the most common causes of morbidity during the first week of life. High serum bilirubin level leads to serious consequences and neurologic disorders in some of the infants with jaundice. 5-10% of these newborns have clinically important neonatal jaundice that requires treatment and care to prevent neurotoxicity and reduce serum bilirubin level (Madan, Mac Mohan, Stevenson, 2005). Recent studies in the literature have shown that there is a strong relationship between hyperbilirubinemia and breastfeeding (Garg, 2018; Flaherman 2017). In a study, it was indicated that breastfed infants had lower bilirubin levels on postnatal day 3 compared to infants fed with infant formula. The problem of jaundice that increases due to insufficient intake of breast milk/breastfeeding is usually underestimated, an exaggerated physiological jaundice treatment is often administered (symptomatically phototherapy), and breastfeeding problems are neglected (Stark, Bhutani 2016). Therefore, while the infant and the mother try to adapt to each other for successful breastfeeding, the treatment process increases breastfeeding difficulties and failure during the first postnatal week. The role and counseling of the infant's nurse are of great importance in breastfeeding of the newborn and the education of the family in neonatal jaundice. The first postnatal hours and days are the most critical times for ensuring the success of breastfeeding. Jaundice due to breastfeeding failure requires focused efforts for a program structured with breastfeeding education and special breastfeeding support. This support causes the role of nurses to become even more important.
Method: This is a randomized controlled experimental study. The data of the study will be collected from primiparous mothers who had normal delivery in the Gynecology and Obstetrics Department in Sakarya Maternity and Children's Hospital Campus affiliated to the Ministry of Health Sakarya University Training and Research Hospital between 01.08.2020-01.01.2021 and their infants until January 2021. The sample of the study was calculated in accordance with the intervention group selection criteria and by performing power analysis. Power analysis was performed using G*Power (v3.1.7) program in order to determine sample size. The effect range value was taken as 0.70 as the method used in cases where it is unknown how many units difference is significant between the groups. In cases where Type 1 error probability (α) was 0.05 (at a confidence level of 95%), at a power level of 80% and the effect range was 0.70, the study was planned with a total of 68 mothers, including 34 mothers women for each group. The mothers to be allocated to the study and control groups will be ensured to have similarity in terms of three factors (age, educational status, gender of the infants). The individuals will be allocated into groups by simple random sampling. The sample of the study will be randomly allocated into two groups: the intervention group will be supported for breastfeeding and the feeding of infants' with breast milk, and the other group, which was the control group, will be followed in routine care of the service. Single-blind (researchers are not blind) randomization will be provided since the mothers will be provided with support for breastfeeding and the feeding of infants' with breast milk by the researchers. The statistician was also blinded for the data analysis purpose. With regard to data collection tools, the "Mother Introductory Information Form" including socio-demographic characteristics of the family, the "Newborn Introductory Information Form" including characteristic features of the infants, the "Infant Nutrition Follow-up Form" for the follow-up of breast milk milked after breastfeeding, and the "Jaundice Follow-up Form" including the follow-up of infants who are hospitalized due to jaundice before/after discharge will be used. Mothers in the experimental group will be provided with breastfeeding support, and if required, the mother's both breasts will be milked by hand and the resulting breast milk will be collected in a container. After milking, the milk will be given to the infant with the help of a teaspoon. This practice will be shown to the mother and will be performed after each feeding during the hospital stay. Mothers will be told to perform this practice at home until the infant sucks effectively and strongly, and families will be called by phone daily. No intervention will be made to the control group. Bilirubin measurements of both groups will be performed with a transcutaneous bilirubin meter both before discharge from the hospital and at the end of week 1, and the values will be recorded. At the same time, the conditions of rehospitalization due to jaundice at the end of week 1 will be recorded. In the evaluation of data, statistical analyses will be performed using the SPSS package program. The Kolmogorov-Smirnov (K-S) test will be used for normality. In order to determine whether there is a difference in the dependent variables compared to independent variables, the independent group t-test will be used if the distribution is normal in independent variables with two options, and Mann Whitney-U test will be used if distribution is not normal. The results will be evaluated at a confidence level of 95% and at a level of significance of p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Support for breastfeeding and the feeding of infants' with breast milkThe support for breastfeeding and the feeding of infants' with breast milk will be conducted in one stage for the experimental group. (1) breastfeeding support education. The content of the support for breastfeeding and the feeding of infants' with breast milk and the materials used were determined by the researchers in accordance with the literature. The content of the support for breastfeeding and the feeding of infants' with breast milk consists of the titles of the importance of breastfeeding and breast milk, the effect of breast milk on preventing jaundice, the importance of early start of breastfeeding, breastfeeding techniques and positions in infants, milking, storage and later use of milk, increasing the quantity and quality of milk, and nutrition of the mother during breastfeeding. Breastfeeding support will be provided in the postpartum service and lactation outpatient clinic of the relevant hospital. |
| Control Groups | No intervention | –The infants in the control group will be followed up in routine service. No intervention will be made. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- • Normal delivery of the mother
Key exclusion criteria (1 listed)
- • Separation of the mother and the infant due to any situation
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 |
|---|---|---|
| Support for breastfeeding and the feeding of infants' with breast milkThe content of the support for breastfeeding and the feeding of infants' with breast milk consists of the titles of the importance of breastfeeding and breast milk, the effect of breast milk on preventing jaundice, the importance of early start of breastfeeding, breastfeeding techniques and positions in infants, milking, storage and later use of milk, increasing the quantity and quality of milk, and nutrition of the mother during breastfeeding. | Other | Experimental |
Primary outcome
Measurement of bilirubin with a Transcutaneous bilirubinometer in the study and control groups
Time frame: Change between the 1 day of discharge from hospital and the 7th day
The device is suitable for use in newborn infants. The device measures by reader head's contact with the infant's forehead and by preventing user's possibility of making a mistake. The device shows the result on the LCD screen after 5 separate readings or has single and average measurement system. A value of above 5-7 mg/dl in the newborn is hyperbilirubinemia.
1 secondary outcome
hospitalization due to jaundice in the study and control groups
Time frame: 7 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. typically after the end of the study
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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.
Pinar Tabakoglu, MSc principal investigator
Sakarya University
Vedat Cinar, MSc principal investigator
Sakarya University
nursan cinar, professor study director
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support for breastfeeding and the feeding of infants' with breast milk in people with Hyperbilirubinemia, Neonatal and Jaundice, Neonatal, run by Sakarya 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: status not confirmed, as of the sponsor's last update on 26 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özge Karakaya Suzan, R.A (05548037580 ext. +90264 295 434, ozgekarakayasuzan@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of bilirubin with a Transcutaneous bilirubinometer in the study and control groups (time frame: Change between the 1 day of discharge from hospital and the 7th day). 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 26 Jun 2020.