Clinical and Developmental Outcomes of Babies Who Became Yellow in the First Month of Life

NCT02927093 | Completed

• 1 other identifier: SMRU 1605
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Shoklo Malaria Research Unit (SMRU) provides care to refugees and migrant populations along the Thai-Burma border since 1986. Services include antenatal and birthing care, with 2,500 births per year and Special Care Baby Units (SCBU) set up in 2008; all medical records including clinical and laboratory data are archived. The treatment of neonatal jaundice is based on treatment thresholds adapted from the neonatal jaundice guidelines, published by the Royal College of Obstetricians and Gynaecologists, UK. Total serum bilirubin (SBR) is done at regular intervals to monitor neonatal hyperbilirubinemia (NH) evolution, following SMRU guidelines. The SCBU have been set up to provide intensive care for neonates in a resource constrained setting and don't have equipment for assisted ventilation other than oxygen therapy. Neonates presenting with high serum bilirubin levels and/or clinical signs of acute bilirubin encephalopathy (ABE) cannot receive exchange transfusion on site and have to be referred to the Thai general hospital one hour drive from the clinics; and, for those neonates surviving, there has not been a systematic follow-up of their growth and neurodevelopment. The study will consist of a matched case-control series and a retrospective review of SCBU charts of neonates with NH reaching exchange transfusion threshold. The SCBU database will be searched for neonates born at ≥ 28 weeks of gestation hospitalized for phototherapy between January 2009 and December 2014; charts will be manually researched to identify study participants which will be classified as NH reaching exchange transfusion threshold (cases) or as NH within moderate threshold (controls). Additionally neurological signs compatible with ABE will be searched in the clinical notes and coded as present/absent. Cases discharged alive from the SCBU will be traced back to evaluate their clinical and neurocognitive long term outcome. Each case will be matched with a moderate NH control from the same clinic, sex, gestational age and season of birth and hospitalized within the same month. The results of this study will help to improving the clinical care during the neonatal period and to developing a guideline for a better follow-up of children with NH reaching exchange transfusion threshold.

Conditions

Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (3)

• Visual Function Scores

  The odds ratio of visual function scores between survivors of NH reaching exchange transfusion threshold and those with moderate NH

  8 years

• Neurodevelopmental scores

  The odds ratio of neurodevelopmental scores between survivors of NH reaching exchange transfusion threshold and those with moderate NH

  8 years

• Clinical status

  The clinical status between survivors of NH reaching exchange transfusion threshold and those with moderate NH

  8 years

Secondary Outcomes (8)

• Mortality rate

  8 years

• Proportion of neonates with ABE

  8 years

• Proportion of neonates with G6PD deficiency

  8 years

• Proportion of neonates with ABO incompatibility

  8 years

• Proportion of neonates with polycythaemia

  8 years

Study Arms (2)

Case

neonates with NH reaching exchange transfusion threshold

Control

neonates with NH within moderate threshold of the phototherapy charts

Eligibility Criteria

• Age: 28 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liveborn, singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU, from 1st January 2009 to 31st December 2014 will be included.

You may qualify if:

• Cases
• Liveborn, singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting one or more of the following criteria:
• Two consecutive SBR measures above the exchange transfusion threshold of the phototherapy charts for gestational age
• SBR levels rising \> 8.5 µmol/L per hour
• One or more neurological signs compatible with ABE in the absence of other known neurological condition and in the presence of confirmed NH
• Controls
• Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting all of the following criteria:
• At least one SBR between the moderate and the severe threshold of the phototherapy charts for gestational age
• No SBR above the severe threshold at any time point
• No reported abnormal neurological signs (i.e. convulsions, abnormal cry or tone)
• Each case who has been discharged alive from the SCBU will be matched to one control from the same clinic, sex, gestational age, season of birth and hospitalized within the same month and the clinical and neurodevelopment of both children will be conducted once.

You may not qualify if:

• Stillborn
• Twins
• Liveborn \< 28 weeks gestation
• Major congenital malformation
• Liveborn singleton, ≥28 weeks gestation, hospitalized outside SMRU SCBU
• Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU without SBR done or with all SBR below the moderate threshold of the phototherapy charts for gestational age

Sponsors & Collaborators

• University of Oxford: lead

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 6, 2016
• Study Start: October 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share