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Hyperbilirubinemia, Neonatal clinical trials

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NCT ID: NCT02807246 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Effects of Probiotics on Neonatal Hyperbilirubinemia

Start date: December 2014
Phase: N/A
Study type: Interventional

This study was designed as a prospective controlled study to investigate the effects of probiotic support started immediately after birth on newborn jaundice in breastfed babies born by normal spontaneous vaginal delivery.

NCT ID: NCT02361788 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)

Start date: January 28, 2015
Phase:
Study type: Observational

Background: Neonatal hyperbilirubinemia is the most common reason for admission in the neonatal period (first month of life) worldwide and at SMRU. The skin of the newborn baby becomes jaundiced, which is caused by a high level of bilirubin in the blood. In some neonates the level of bilirubin increases to a level that can cause braindamage or even death. There are different causes known that can lead to higher levels of bilirubin, for example G6PD deficiency and prematurity. In case of neonatal hyperbilirubinemia the neonate needs to be treated with phototherapy (blue light therapy). If there is prolonged jaundice (≥ 21 days), further investigations needs to be done. Objectives: Primary objective: To determine the etiology of neonatal hyperbilirubinemia in neonates with a gestational age of ≥ 28 weeks from the refugee and migrant population, on the Thai-Myanmar border. Secondary objective: - Establishing the incidence of neonatal hyperbilirubinemia - Determine the risk factors for the development of neonatal hyperbilirubinemia - Determine the incidence of prolonged neonatal jaundice - Determine the neurodevelopmental outcome, at the age of 6 and 12 months - Determine the body composition, using air-displacement plethysmography, at birth, 1, 2 and 3 months of age - Determine the incidence of anaemia and illness episodes during the first year of life - Determine the incidence of helminthic infection at the age of one year - Assess the knowledge level and misbeliefs on neonatal hyperbilirubinemia among the mothers and SMRU health care staff Research design: The study will conduct an exhaustive prospective descriptive study, all eligible newborns will be enrolled after obtaining the informed consent from their mothers. During pregnancy and delivery we will collect clinical data about the mother. At birth we will take umbilical cord blood (9 ml) to test for different causes of neonatal hyperbilirubinemia. In the first week of life we plan 4 moments to measure the bilirubin and hematocrit level (0.05 ml), weight and ask questions about feeding and other practices. Based on the bilirubin results we will determine whether the neonate needs phototherapy. After the first week we weekly follow-up will be conducted and in case of visible jaundice we will measure the bilirubin level. If the neonate is still jaundiced after the age of 21 days we will further investigate the cause. In the infant period, until the age of one year, we plan to have monthly follow-up to assess the health and growth of the child and at the age of 3, 6 and 12 months we will do a neurodevelopmental test. An improved understanding of the pathological processes contributing to the development of neonatal hyperbilirubinemia is needed in order to to identify neonates at risk and develop improved management.

NCT ID: NCT02154165 Completed - Clinical trials for Uncomplicated Neonatal Hyperbilirubinemia

Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes

Start date: January 2013
Phase: N/A
Study type: Interventional

The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Though, previous studies used light tubes, today we use light emitting diodes (LED'S). The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus blue LED's for decreasing total serum bilirubin in neonates with gestational age > 33 weeks and uncomplicated hyperbilirubinemia.

NCT ID: NCT02033096 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)

Start date: October 20, 2008
Phase:
Study type: Observational

Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993). No interventions were administered during this follow-up study.

NCT ID: NCT02000830 Completed - Clinical trials for Hyperbilirubinemia, Neonatal

Follow up Study of Patients Having Participated in Clinical Trial 64,185-204

JASMINE_205
Start date: October 17, 2013
Phase:
Study type: Observational

The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.

NCT ID: NCT01887327 Completed - Jaundice, Neonatal Clinical Trials

Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

JASMINE_204
Start date: October 16, 2013
Phase: Phase 2
Study type: Interventional

It is normal for red blood cells to die, even in newborn babies. The waste from that is called bilirubin. The liver clears bilirubin out of the body. Some babies are born with illness that makes red blood cells die too fast, so the liver is not strong enough to keep up with it. The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high. Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of bilirubin. This study tests an experimental drug to see if it can help the liver even more, by safely cutting down the amount of bilirubin the body is making in the first place.

NCT ID: NCT01763632 Completed - Clinical trials for Hyperbilirubinemia, Neonatal

Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants

Start date: January 2013
Phase: N/A
Study type: Observational

Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram. The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.

NCT ID: NCT01762189 Completed - Clinical trials for Hyperbilirubinemia, Neonatal

The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Start date: January 2013
Phase: N/A
Study type: Observational

Thirteen hospitals in China will participate in the study, which aims to provide data on serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes. We hypothesize that the study can be value in identifying and implementing strategies for risk reduction.

NCT ID: NCT01746511 Completed - Prematurity Clinical Trials

Glycerin Suppositories to Reduce Jaundice in Premature Infants

Start date: July 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to find out if giving glycerin suppositories will help decrease the length of time premature infants need phototherapy. The investigators hypothesize that glycerin suppositories (initiated along with phototherapy) will have no effect on reducing duration of phototherapy in premature infants with jaundice.

NCT ID: NCT01599611 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study

Start date: March 2010
Phase: N/A
Study type: Observational

The objective of this study was to investigate whether infants with total serum bilirubin > 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.