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Intraumbilical Amino Acids and Glucose Supplementation Via Port by Severe IUGR in Human Fetuses (port-IUGR)

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ClinicalTrials.gov Identifier: NCT02596594
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Tchirikov MD, PhD, Martin-Luther-Universität Halle-Wittenberg

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.


Condition or disease Intervention/treatment Phase
Intrauterine Growth Restriction Device: fetal nutrition port system Not Applicable

Detailed Description:

Placental insufficiency is the main source of the development of intrauterine growth restriction (IUGR) caused by one of a variety of factors including chronic placental infections, many maternal diseases, abnormal genome and intravascular trophoblast invasion impairment. Placental insufficiency is responsible for fetal loss in about 40% of all stillbirths and long term neurological deficits. The reduction of blood flow resistance of cerebral arteries in severe IUGR conditions with reduced pulsatility index (PI) in the medial cerebral artery predicts the 11 fold increased risk of intraventricular hemorrhage, periventricular leukomalacia, hypoxic ischemic encephalopathy, necrotizing enterocolitis, bronchopulmonary dysplasia, sepsis, and death. The mean interval from diagnosis of brain sparing of severe IUGR fetuses to delivery has been recently identified by only seven days (ranging 2-15 days).

The amino acids (AA) concentration of fetal plasma is many times higher than in mother because of active transplacental transport of AA and additional AA synthesis in the placenta.

The critical placental player in the active 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 IUGR changed fetal programming and to prolong the pregnancy. Additional oxygen supply of fetal tissues could also be important in improving the uptake of injected nutritional supplements and may avoid the development of lactate acidosis in IUGR fetuses.

The aim of this prospective pilot study was 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.

Study design - IUGR was defined in this study as an estimated fetal weight of < 5%, combined with increased resistance in both uterine arteries with pulsatility index (PI) > 95%. Fetuses with morphological and/or chromosomal abnormalities were not included in the final analysis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intraumbilical amino acid and glucose suplementation of human fetuses with a severe IUGR via a subcutaneously implanted port system
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Intraumbilical Amino Acids and Glucose Supplementation Via Subcutaneously Implanted Port System by Severe IUGR Human Fetuses
Study Start Date : January 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Port intervention

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
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.

No Intervention: control

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




Primary Outcome Measures :
  1. The mean interval from diagnosis of brain sparing of severe IUGR fetuses to delivery [ Time Frame: through study completion, up to 2 years ]
    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.


Secondary Outcome Measures :
  1. neonatal weight [ Time Frame: through study completion, up to 2 years ]
    the neonates' weight will be estimated after the delivery

  2. fetal weight gain [ Time Frame: through study completion, up to 2 years ]
    the difference (g) between estimated by ultrasound fetal weight and neonatal weight at delivery

  3. blood gas analysis in the umbilical artery [ Time Frame: through study completion, up to 2 years ]
    the blood gas analysis in the umbilical artery will be performed after the delivery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. multiple pregnancy
  2. fetal genetic anomalities,
  3. fetal morphologic anomalities
  4. BMI > 35
  5. placenta praevia
  6. vaginal bleeding
  7. uterine contractions
  8. vasa praevia
  9. posterior location of the placenta
  10. severe maternal morbidities
  11. Infections
  12. preliminary rupture of the membranes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596594


Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
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Principal Investigator: Michael Tchirikov, MD, PhD Martin-Luther University Halle-Wittenberg
Publications:
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Responsible Party: Michael Tchirikov MD, PhD, MD PhD, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT02596594    
Other Study ID Numbers: 110; 3/15-08-2012
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Keywords provided by Michael Tchirikov MD, PhD, Martin-Luther-Universität Halle-Wittenberg:
IUGR
severe IUGR
brain sparing
fetal nutrition
Prolongation
pregnancy
neonatal outcome
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes