Condition category
Neonatal Diseases
Date applied
01/10/2019
Date assigned
08/11/2019
Last edited
24/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.biruni.edu.tr/

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

Publication citations

Additional files

Editorial Notes

24/10/2019: Trial’s existence confirmed by Medipol Mega University Hospital Ethical Committee (Medipol Mega Üniversitesi Hastanesi Etik Kurulu)