The Effect of Breastfeeding Support on Hospitalization Due to Jaundice

NCT04445675 | Unknown

• 1 other identifier: Ozge
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Keywords

Newborn; Hyperbilirubinemia; Breastfeeding support; Nurse

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  7 days after discharge

Study Arms (2)

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.

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.

Interventions

Support for breastfeeding and the feeding of infants' with breast milk OTHER

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: breastfeeding mothers'
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• Separation of the mother and the infant due to any situation

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

sakarya University

Sakarya, 54000, Turkey (Türkiye)

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Hyperbilirubinemia

Interventions

Palliative Care; Lactation; Milk, Human

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Pinar Tabakoglu, MSc

  Sakarya University

  PRINCIPAL INVESTIGATOR

• Vedat Cinar, MSc

  Sakarya University

  PRINCIPAL INVESTIGATOR

• nursan cinar, professor

  Sakarya University

  STUDY DIRECTOR

• Sultan Peksen

  Sakarya University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• özge Karakaya Suzan, MSc

  Sakarya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özge Karakaya Suzan, R.A

CONTACT

05548037580; ozgekarakayasuzan@sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: reseaech asistant

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: August 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: January 1, 2021
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

TU (1)