Plain English Summary
Background and study aims
Hyperbilirubinemia is a condition in which there is too much bilirubin in the blood. When red blood cells break down, a substance called bilirubin is formed. Babies are not easily able to get rid of the bilirubin and it can build up in the blood and other tissues and fluids of the baby's body.
Newborn massage is one of the complementary treatments that can be used to lower bilirubin levels. Bilirubin is removed from the body by defecation and abdominal massage increases the bowel movement frequency of the newborn infants.
Therefore, this study has planned to determine the effect of abdominal massage intervention on term newborn infants receiving phototherapy on transcutaneous bilirubin levels as a randomized controlled trial.
Who can participate?
Newborns with hyperbilirubinemia who are undergoing phototherapy treatment
What does the study involve?
Participants will be randomly allocated to either receive standard care or standard care with the addition of abdominal massage for two days
What are the possible benefits and risks of participating?
The newborn ınfants who participating the study is undertaken phototherapy and have hyperbilirubinemia. The massage intervention is thought to reduce bilirubin by accelerating defecation. This is the primary benefit of the study. Also, this massage intervention can be taught to families and can be used to relieve the infant, to prevent constipation, and to relieve it emotionally. This can be thought the secondary benefit of massage. Since the intervention does not involve an invasive procedure, it is considered that there is no risk because no drug is administered
Where is the study run from?
Mega Medipol University Hospital, Turkey
When is the study starting and how long is it expected to run for?
October 2019 to March 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Özge Eda Yılmaz
ozgedak@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Özge Eda Yılmaz
ORCID ID
http://orcid.org/0000-0001-5063-4907
Contact details
İstanbul Üniversitesi-Cerrahpaşa Florence Nightingale Hemşirelik Fakültesi
Abide-i Hürriyet cad Şişli
İstanbul
34381
Turkey
+90 212 4040300
Ozge.karadag@istanbul.edu.tr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
10840098-604.01.01-E.29907
Study information
Scientific title
Comparison of bilirubin levels and physiologic signs according to abdominal massage intervention on term newborn infants in phototherapy: randomized clinical trial
Acronym
Study hypothesis
H1. The transcutaneous bilirubin levels of term infants who applied abdominal massage are lower than who do not apply
H2. The number of bowel sounds of term infants who applied abdominal massage are more than who do not apply
H3. The heart rates of term infants who applied abdominal massage are lower than who do not apply
H4. The level of Oxygen saturations of term infants who applied abdominal massage is higher than who do not apply
Ethics approval
Approved 16/07/2019, Medipol Mega University Hospital Ethical Committee (Medipol Mega Üniversitesi Hastanesi Etik Kurulu; Kuzey Kampüsü Kavacık Mah. Ekinciler Cad. No.19 Kavacık Kavşağı – Beykoz 34810 İstanbul, Turkey; ilknurfil@medipol.edu.tr; +90 444 85 44 – 5137), ref: 10840098/604.01.01-E.29907
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Hyperbilirubinemia, Jaundice
Intervention
This study has planned to determine the effect of abdominal massage intervention on term newborn infants receiving phototherapy for hyperbilirubinemia on transcutaneous bilirubin levels.
Baseline measures of transcutaneous bilirubin, SpO2, heart rate, bowel movement sounds will be taken
Experimental Group: Abdominal massage will be applied for 2 days, at least with 6 hours intervals 3 times a day for 6 sessions as 5 min for each session by the nurse who has a massage certificate
Abdominal Massage Intervention Steps
First step: Before the massage, the researcher will wash her hands and use the baby lotion to provide lubrication during the massage.
Second step: After the abdominal massage will start from the right side of the infant’s abdomen, the fingers will be moved to the left side with slight pressure. The expert nurse who will do massage will move her hands from the abdomen to the inguen in a clockwise direction by applying slight pressure.
Third step: The infant’s legs will be lifted up. Gentle pressure will be applied to the infant’s abdomen by helping abdomen muscles to relax. The nurse will lift up the infant’s legs with her left hand by holding his/her ankles and apply slight pressure on his/her legs with her right hand.
Fourth step: After it will be pressed gently with the hands, the circular movements will be applied from the right inguen to the left inguen and legs in a clockwise direction
Control Group: Standard hospital care
Both group’s data will be recorded at the time when the phototherapy is interrupted and the baby will be allowed to rest for 5 minutes and then transcutaneous bilirubin level, sounds of bowel movements, oxygen saturation, and heart rate will be evaluated and recorded on the observation form. These measurements will be made 3 times a day at least 6 hours intervals. For the experimental group, the measurements will be recorded before massage intervention.
The participants will be randomised by the Urn method (selection at random of a coloured ball from a closed bag)
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Serum bilirubin level; routinely check every 24 hours in the neonatal unit.
2. Transcutaneous bilirubin level; will check from forehead before starting phototherapy.
3. Oxygen saturation: will check from pulse oximeter before starting phototherapy mean value for one minute after relaxed for 5 minutes
4. Heart rate: checked from pulse oximeter before starting phototherapy mean value for one minute after relaxed for 5 minutes
5. Sounds of bowel movements: the bowel movements will auscultate from over all four quadrants, 1 minute for each quadrant, total 4 minutes.
6. Serum bilirubin measurement will be repeated at the 48th hour of phototherapy after the last massage session (6th Session) -at least 6 hours later - in newborns in the experimental group
7. In newborns in the control group, blood bilirubin measurement will be repeated at 48 hours of phototherapy
Secondary outcome measures
1. Feeding type (breastfeeding or formulated bottle feeding):
1.1 For the newborns who breastfeed:
1.1.1 Duration of breastfeeding (minute)
1.1.2 Test weight of infant (g)
1.1.3 Number of breastfeeding (number/day) will be recorded
1.2 For the newborns who formulated feeding
1.2.1 Duration of feeding (minute)
1.2.2 Number of feeding (number/day)
1.2.3 Amount of each feeding (ml)
2. For both groups, the number of feces will be recorded for 2 days on the observation form
Overall trial start date
01/06/2019
Overall trial end date
30/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Family willing to participate in the research
2. Birth between gestational weeks > 37 and <42
3. Birth weight >2500 and <4000 g
4. Postnatal first minute APGAR score >7
5. Phototherapy treatment for the first time
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
For each cluster 30 infants, total 60 infants will be planned
Participant exclusion criteria
Physical examination of the newborn performed by the physician and decided to another health problem other than hyperbilirubinemia
Recruitment start date
15/10/2019
Recruitment end date
15/03/2020
Locations
Countries of recruitment
Turkey
Trial participating centre
Mega Medipol University Hospital
Tem Avrupa Oto Yolu
Bağcilar
Istanbul
34214
Turkey
Sponsor information
Organisation
Biruni University
Sponsor details
10. Yıl Caddesi Protokol Yolu No: 45 Topkapı
Istanbul
34010
Turkey
444 8 276
info@biruni.edu.tr
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We would like to plan to complete data collection in December 2019 than we'll start to analyze the findings. We would plan to write a research report according to results until June 2020. As soon as we complete the research report, we would submit the manuscript to an SCIE or SCI journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.
Study Protocol, Statistical Analysis Plan, Informed Consent Form, will be available, beginning 9 months and ending 36 months following article publication from the corresponding author on reasonable request.
Intention to publish date
30/12/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list