Neonatal Jaundice Clinical Trial
Official title:
Investigation of the Effect of Massage on Bilirubin Level in Preterm Infants
Jaundice (hyperbilirubinemia) which is one of the common causes of repeated hospitalizations in the neonatal period, is a physiological condition seen in 60% of term babies and 80% of premature babies in the first week of life . Premature babies are more susceptible tobilirubin neurotoxicity. Death and severe sequelae due to hyperbilirubinemia can be prevented by early diagnosis and treatment. Massage is one of the applications that can be used to reduce bilirubin levels in newborn infants. Baby massage facilitates bowel movements and bilirubin excretion by reducing enterohepatic circulation. This study was designed as a randomized controlled trial to investigate the effect of massage on bilirubin levels in premature infants.
Neonatal jaundice is a physiological condition seen in 60% of infants and 80% of preterm
infants in the first week of life. There is no clear data on the frequency of jaundice in
newborns in our country. Jaundice is one of the common causes of 75% of hospitalizations in
the first week after birth and the recurrence of hospitalizations in the neonatal period.
Neonatal jaundice is a non-hazardous and transient condition that can usually resolve
spontaneously without treatment. Although it is a transient condition, high bilirubin levels
can cause kernicterus which causes severe neurological damage if not diagnosed and treated
early .
The severity and complications of hyperbilirubinemia in premature infants are different from
term infants. Premature infants are more susceptible to damage caused by serum bilirubin,
even at low levels of brain cells. Hyperbilirubinemia in preterm infants is more prevalent,
severe, and protracted than that in term infants because of the immaturity of their red blood
cells, livers, and gastrointestinal tracts. There also is often a delay in enteral feeds,
which may limit intestinal flow and bacterial colonization, resulting in further enhancement
of the enterohepatic circulation of bilirubin. Preterm neonates are more susceptible to
bilirubin neurotoxicity. Almost all preterm infants less than 35 weeks gestational age have
elevated total serum/plasma bilirubin levels, which results in neonatal jaundice, the
yellowish discoloration of the skin and conjunctiva caused by bilirubin deposition. The major
complication of an elevated total serum (hyperbilirubinemia) is bilirubin-induced neurologic
dysfunction (BIND), which occurs when circulating bilirubin crosses the blood-brain barrier
and binds to brain tissue . Jaundice is an important problem in newborn infants and death and
severe sequelae due to hyperbilirubinemia can be prevented by early diagnosis and treatment.
Various treatment methods have been developed to reduce bilirubin levels. The most commonly
used methods are; blood exchange, phototherapy and pharmacological agents. Therapeutic
interventions prevent BIND and thus kernicterus by lowering the level of bilirubin in the
blood. Phototherapy is a common treatment for both treatment and prevention of increased
bilirubin levels. Phototherapy has been widely used in the treatment of hyperbilirubinemia of
the newborn for more than fifty years. Phototherapy has various side effects, such as damage
to the retina and genitalia, loss of body water, skin rashes, watery stools and Bronze Baby
Syndrome.
Nowadays, studies on new treatment methods and different applications are being made which
support the treatment of jaundice and shorten the length of hospital stay. Kangaroo care
reduces the exposure of newborns to phototherapy, swimming, wiping and bathtub bathing have
been reported to reduce bilirubin levels. Baby massage is one of the alternative and
complementary therapies that can be used to reduce bilirubin levels.
While there are many studies investigating the effect of infant massage on bilirubin levels
in term neonates with healthy and hyperbilirubinemia, a limited number of studies
investigating the effect of massage on bilirubin levels in premature infants were found.
It is suggested that baby massage can be performed by trained nurses and mothers trained by
nurses. Infant massage stimulates defecation by increasing bowel movements, thus decreasing
enterohepatic circulation and increasing bilirubin excretion. Bilirubin excretion decreases
the speed and severity of hyperbilirubinemia. In some studies investigating the effect of
massage on bilirubin levels, transcutaneous bilirubin (TcB) levels or TSB levels were found
to be significantly lower, also no significant difference was found in some studies.
In our country, the studies on the benefits of baby massage for infants are quite new. There
are two studies investigating the effect of massage on bilirubin levels in newborn infants.
However, in one of these studies, the effect of infant massage on bilirubin levels in
newborns who received phototherapy was investigated, while the effect of abdominal massage on
TcB bilirubin levels in newborns was investigated in the other study. TSB levels are the gold
standard in the evaluation of bilirubin levels in newborn infants. However, the blood needs
to be taken from the baby, and taking blood is a painful procedure, and it may not always
possible to get enough blood. Measurement of bilirubin level from the skin surface is both
noninvasive, painless and simple. In this study, the effect of infant massage on bilirubin
level in premature infants not receiving phototherapy was evaluated by transcutaneous
bilirubin measurement method. This study was designed as a randomized controlled trial to
investigate the effect of massage on bilirubin levels in premature infants.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04365998 -
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
|
N/A | |
Completed |
NCT02222805 -
Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment
|
N/A | |
Completed |
NCT01622699 -
Implementation of a Transcutaneous Bilirubinometer
|
N/A | |
Completed |
NCT00692224 -
Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06080971 -
Persistent Neonatal Jaundice on Neonates and Childern
|
||
Recruiting |
NCT06075290 -
the Difference of Follow-up Methods of Neonatal Jaundice
|
||
Recruiting |
NCT05955144 -
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
|
N/A | |
Recruiting |
NCT05127070 -
Evaluating the NeoTree in Malawi and Zimbabwe
|
||
Completed |
NCT03306004 -
Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho
|
N/A | |
Completed |
NCT02774434 -
Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
|
N/A | |
Terminated |
NCT05365399 -
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
|
N/A | |
Recruiting |
NCT03933423 -
Home Based Phototherapy for Neonatal Jaundice
|
N/A | |
Recruiting |
NCT06087874 -
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
|
Phase 2 | |
Recruiting |
NCT06399146 -
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana
|
N/A | |
Recruiting |
NCT03183986 -
Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.
|
N/A | |
Withdrawn |
NCT00917007 -
Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
|
||
Completed |
NCT06227624 -
Role of Oral Zinc in Reducing Neonatal Indirect Hyperbilirubinemia
|
Phase 3 | |
Completed |
NCT04433923 -
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants
|
N/A | |
Completed |
NCT04418180 -
Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants
|
N/A | |
Completed |
NCT06386731 -
Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice
|
N/A |