RecruitingACTRN12617001049369

comparison of umbilical venous catheter versus central lines in incidence of brain hemorrhage in preterm infants

Does the use of peripherally inserted central catheters compared to umbilical venous catheter reduce the incidence of brain hemorrhage in preterm infants?


Sponsor

Atef Alshafei

Enrollment

200 participants

Start Date

Jul 25, 2017

Study Type

Interventional

Conditions

Summary

Intraventricular hemorrhage (IVH) is a common problem affecting significant number of preterm infants with devastating long-term outcome. The etiology of IVH is multifactorial and attributed mainly to disturbance of cerebral blood flow. Placing UVC shortly after birth would keep ductus venosus opened and simulate the unique preferential blood flood flow of fetal circulation via inferior vena cava to the right atrium and then patent foramen ovale PFO to the left atrium. This would directly influences the cerebral blood flow stability in that subset of infants with a limited cerebral autoregulation. This does not happen under physiological conditions with drop of pulmonary blood pressure soon after birth and reverse of shunt through PFO from left to right. In sick preterm infants with RDS and variable degrees of hypoxemia, the pulmonary pressure remains at higher levels for considerable time with occasional right to left or bidirectional shunt. On the other hand, placing PICC instead would avoid the direct pathway through PFO to left atrium and eventually to the brain. Accordingly, in this way it could theoretically reduce the incidence of IVH by avoiding the swinging of cerebral blood flow. This prospective study will be conducted at NICU, Dubai hospital. Dubai, UAE. 200 preterm infants with gestational age ranging from 24 to 30 weeks (mean GA 27 weeks) and weight range from 500 Gm to 1500 Gm. will be enrolled in the study, 100 infants in each arm (UVC group and PICC group). NICU registrar on call will open a sequentially numbered, sealed, opaque envelope indicating the treatment arm, either UVC or PICC insertion. Demographic data including GA, weight, gender, antenatal steroids, mode of delivery, Apgar score, resuscitation, mode of ventilation support, hemodynamic stability, and surfactant administration will be considered equally on assignment of infants to either group. Routine cranial ultrasound will be carried out by trained neonatologists according to NICU policy, first scan on day 3 – 7, second scan on day 10-14 and third on 34-36 weeks GA and before discharge.to check the presence of IVH, the grade, and associated complications PVL or post -hemorrhagic ventricular dilatation. Statistical analysis of collected data comparing the two groups will be carried on to answer the question if central lines insertion is superior to UVC in decreasing the incidence of IVH in sick preterm infants in the first 2 weeks of life.as primary outcome .


Eligibility

Sex: Both males and femalesMin Age: 1 HoursMax Age: 4 Hourss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether the type of central line (a thin tube placed into a large blood vessel) used in very premature babies affects the risk of bleeding in the brain (called intraventricular hemorrhage or IVH). Brain bleeds are a serious and common problem in premature babies. Some researchers think that one type of central line (placed through the belly button, called a UVC) might affect blood flow to the brain differently than another type placed through a limb vein (called a PICC line). This study compares the two in premature babies. You may be eligible if: - Your baby was born between 24 and 30 weeks of pregnancy - Your baby was admitted to the NICU at Dubai Hospital You may NOT be eligible if: - Your baby has a major birth defect - Your baby was diagnosed with a brain bleed (IVH) before birth - Your baby was born after 30 weeks of pregnancy - Your baby has a bleeding disorder - Your baby was born outside the hospital Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intraventricular hemorrhage (IVH) is a common problem affecting significant number of preterm infants with devastating long-term outcome. Different contributing etiologies have been studied to explai

Intraventricular hemorrhage (IVH) is a common problem affecting significant number of preterm infants with devastating long-term outcome. Different contributing etiologies have been studied to explain the cause of IVH. Umbilical venous catheter (UVC) and peripherally inserted central catheters (PICC) are routinely used interchangeably in preterm infants for central venous access. The purpose of this study is to compare the incidence of IVH-PVH in preterm infants using UVC versus those with PICC. 200 preterm infants admitted to NICU, Dubai Hospital will be enrolled prospectively in this study with 100 infants in each arm (UVC group and PICC group). Gestational age of infants will be ranging from 24 to 30 weeks with a mean of 27 weeks. The protocol of NICU is to insert UVC or PICC routinely after stabilization of sick preterm infants for proper administration of medications and parenteral nutrition. UVC or PICC insertion is done after admission to NICU by A well trained neonatologist registrar on call and kept for a total duration of 7-10 days for the UVC and for 2-3 weeks for PICC. Cranial ultrasound scan will be carried on all infants in the two groups as per NICU policy, first scan on day 3 – 7, second scan on day 10-14 and third on 34-36 weeks GA and or before discharge. IVH-PVH grading and associated complications of periventricular leukomalacia PVL and post- hemorrhagic ventricular dilatation PHVD will be recorded for both groups.


Locations(1)

dubai, United Arab Emirates

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ACTRN12617001049369