Intraumbilical Amino Acids and Glucose Supplementation Via Port by Severe IUGR in Human Fetuses

NCT02596594 | Completed DMC

• 1 other identifier: 110; 3/15-08-2012
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

Placental insufficiency is responsible for fetal loss in about 40% of all stillbirths and long term neurological deficits. The mean interval from diagnosis of brain sparing of severe IUGR fetuses to delivery has been recently identified by only seven days (Flood K et al, Am J Obstetrics and Gynecology 2014). The critical placental player in the active amino acids (AA) transport from the mother to the fetus is the trophoblast, which is irreversibly changed in severe IUGR fetuses caused by placental insufficiency. Thus, a logical partial solution of IUGR could be the direct supply of AAs and glucose to the fetus, in order to improve the fetal growth, normalize the fetal programming and to prolong the pregnancy. The aim of this prospective pilot study is to further test the efficacy of the administration of AAs and glucose supplementation with hyperbaric oxygenation (HBO), via a subcutaneously implanted intraumbilical perinatal port system, as a treatment option for severe IUGR human fetuses with brain sparing.

Conditions

Intrauterine Growth Restriction

Keywords

IUGR; severe IUGR; brain sparing; fetal nutrition; Prolongation; pregnancy; neonatal outcome

Outcome Measures

Primary Outcomes (1)

• The mean interval from diagnosis of brain sparing of severe IUGR fetuses to delivery

  The mean interval from diagnosis of brain sparing of severe IUGR fetuses to delivery will be documented (days). The timing of delivery by caesarean section will be decided by the lead clinician managing each case based on doppler and cardiotocogram clinical evaluations.

  through study completion, up to 2 years

Secondary Outcomes (3)

• neonatal weight

  through study completion, up to 2 years

• fetal weight gain

  through study completion, up to 2 years

• blood gas analysis in the umbilical artery

  through study completion, up to 2 years

Study Arms (2)

Port intervention

EXPERIMENTAL

The subcutaneous intraumbilical port-system will be implanted in IUGR patients with the cerebroplacental ratio less than 1 (cerebroplacental ratio= PI in the middle cerebral artery / PI umbilical artery) between 24/0 and 30/0 weeks of gestation. The fetuses will receive AAs and glucose supplementation via a subcutaneously implanted intraumbilical perinatal port system till the delivery. Control by doppler and cardiotocogram

Device: fetal nutrition port system

control

NO INTERVENTION

IUGR patients with the cerebroplacental ratio less than 1 (CPR= PI middle cerebral artery / PI umbilical artery) between 24/0 and 30/0 weeks of gestation. Control by doppler and cardiotocogram

Interventions

fetal nutrition port system DEVICE

Under local anesthesia a subcutaneous pouch for the port capsule was prepared using a pair of scissors. The umbilical vein was punctured with a 18 gauge needle under ultrasound control and the catheter was inserted into the umbilical vein. Note the amniotic cavity remained intact. A 25 gauge port needle was used to enter the port system. The treatment course included daily infusions of AA solution (Fresenius Kabi, Bad Homburg, Germany) with a 10% glucose solution. The investigators limited the volume of the intraumbilical infusion to 10% of the estimated feto-placental blood volume per day. On average, the AA/glucose-infusion was below 50 ml/kg.

Port intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of severe intrauterine growth restricted fetuses with the cerebroplacental ratio less than 1 (CPR= PI middle cerebral artery / PI umbilical artery)
• gestational age between 24/0 and 30/0 weeks
• single pregnancy
• anterior or lateral location of the placenta

You may not qualify if:

• multiple pregnancy
• fetal genetic anomalities,
• fetal morphologic anomalities
• BMI \> 35
• placenta praevia
• vaginal bleeding
• uterine contractions
• vasa praevia
• posterior location of the placenta
• severe maternal morbidities
• Infections
• preliminary rupture of the membranes

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg: lead

Related Publications (1)

• Tchirikov M, Kharkevich O, Steetskamp J, Beluga M, Strohner M. Treatment of growth-restricted human fetuses with amino acids and glucose supplementation through a chronic fetal intravascular perinatal port system. Eur Surg Res. 2010;45(1):45-9. doi: 10.1159/000318859. Epub 2010 Aug 20.

  PMID: 20733317 BACKGROUND

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Tchirikov, MD, PhD

  Martin-Luther University Halle-Wittenberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: Intraumbilical amino acid and glucose suplementation of human fetuses with a severe IUGR via a subcutaneously implanted port system

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: November 4, 2015
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 26, 2018

Record last verified: 2018-01