A randomized, controlled trial of heparin versus placebo infusion to prolong the usability of peripherally placed percutaneous central venous catheters (PCVCs) in neonates: the HIP (Heparin Infusion for PCVC) study. Randomized controlled trial of heparin for prevention of blockage of peripherally inserted central catheters in neonates. Benefit and risk of heparin for maintaining peripheral venous catheters in neonates: a placebo-controlled trial. Efficacy of heparin in peripheral venous infusion in neonates. A randomized trial comparing peripherally inserted central venous catheters and peripheral intravenous catheters in infants with very low birth weight. The effect of cephalothin prophylaxis on postoperative ventriculoperitoneal shunt infections. A randomized trial of heparin and saline for maintaining intravenous locks in neonates. A randomized-controlled trial of prophylactic hydrocortisone supplementation for the prevention of hypotension in extremely low birth weight infants. The efficacy of heparin in maintaining peripheral infusions in neonates.
Mechanical and infectious complications shorten the effective duration of peripherally inserted central venous catheters. Heparin use to prevent such complications and prolong the usability of peripherally inserted central venous catheters is inconclusive.
                Our goal was to evaluate the effectiveness of heparin in prolonging the usability of peripherally inserted central venous catheters in neonates.
                We performed a multicenter, randomized, controlled trial of heparin infusion (0.5 U/kg per hour) versus placebo for peripherally inserted central venous catheters in neonates. The primary outcome was duration of catheter use. Secondary outcomes were occlusion, catheter-related sepsis, thrombosis, and adverse effects of heparin. To detect a 168-hour (1-week) difference in the duration of catheter use, 192 patients were needed. Kaplan-Meier and Cox regression analyses were performed.
                A total of 201 neonates were enrolled (heparin group: n = 100; control group: n = 101). Baseline demographics were similar between the groups. Duration of catheter use was longer in the infants in the heparin versus the placebo group. Study center, gender, birth weight, and type and position of the catheter were not predictors of duration of catheter use. For those in the heparin versus the placebo group, the incidence of elective catheter removal (therapy completed) was 63% vs 42%, of occlusion was 6% vs 31%, of thrombosis was 20% vs 21%, and of catheter-related sepsis was 10% vs 6%, respectively. No adverse events were noted.
                Heparin infusion prolonged the duration of peripherally inserted central venous catheter usability, which permitted a higher percentage of neonates to complete therapy without increasing adverse effects. To determine whether the addition of heparin to total parenteral nutrition (TPN) fluid would prevent blockage of peripherally inserted central catheters (PICCs) in neonates.
                This was a randomized, double-blind, controlled study of 66 eligible neonates with PICCs inserted for the administration of TPN. Infants were randomized to receive TPN containing either 1 IU ml(-1) of heparin (n = 35) or no heparin (n = 31).
                There was no significant difference in the incidence of blocked catheters between the two groups of infants (heparin: 14.3%; no-heparin: 22.6%, p = 0.4). Although a higher percentage (62.9%) of infants in the heparin group received a complete course of TPN successfully via PICC than those in the no-heparin group (48.4%), the difference was not statistically significant (p = 0.3). There were no significant differences in the incidence of catheter-related sepsis, hypertriglyceridaemia, hyperbilirubinaemia, coagulopathy or intraventricular haemorrhage between the two groups.
                Addition of heparin to TPN fluid was not associated with a significant reduction in the incidence of blocked PICCs. However, the sample size of this study was too small to exclude even rather marked differences between the groups. Heparin addition to infusion fluids is used to prolong catheter patency in newborns. Heparin may also induce adverse effects such as bleeding complications and immune-mediated heparin-induced thrombocytopenia (HIT). One objective was peripheral venous catheter patency with heparinization of continuous infusions (0.5 IU/mL). Secondary objectives were incidences of bleeding, clinically manifest HIT, HIT antibodies, and catheter-related complications.
                Inclusion criteria were anticipated need for intravenous peripheral infusion (>or=5 days for HIT-related endpoints) and postnatal age <28 days at study entry. Exclusion criteria were bodyweight <1000 g, congenital malformation, need for therapeutic anticoagulation or mechanical ventilation, and severe bleeding. HIT antibodies were assessed by enzyme-linked immunosorbent assay.
                A total of 145 infants received heparin, and 151 infants received saline. Patient characteristics, number of additional drugs, duration of treatment, and location and size of catheters did not differ. Patency of catheters was 7.4 hours longer in the heparin group (33.8 hours vs 26.4 hours, P<.0001), but the total numbers of catheters did not differ (565 vs 692, P=.3). No infant developed HIT antibodies. Incidences of bleeding complications and thrombocytopenia were comparable between groups.
                Balancing the benefits against the risks of heparin addition and the rare complication of HIT, we will not use 0.5 IU/mL heparin addition to parenteral fluids. To determine the efficacy of continuous, low-dose heparin infusion in prolonging peripheral venous catheter patency in neonates.
                Randomized, prospective study.
                Level III neonatal intensive-care unit.
                113 neonates requiring i.v. therapy.
                The neonates were randomly assigned to heparin (n = 63). The heparin group received 1/2 unit of heparin per milliliter of continuous intravenous infusate or intermittent heparin flush.
                Low-dose heparin infusion does not make a difference in the duration of peripheral venous catheter patency. The incidence of catheter-related complications in the heparin group is the same as for those receiving no heparin.
                The mean duration of catheter patency was 62.75 hours in the heparin group and 27.3 hours in the no-heparin group (p = .0001). The occurrence of infection, bleeding, and extravasation injury was zero in the sample studied. The incidence of phlebitis was 18 cases in 132 (13%) in the heparin group and 13 cases in 122 (10%) in the no-heparin group. According to chi-square analysis, the difference between groups was not statistically significant (p greater than .05).
                Low-dose heparin infusion in peripheral venous catheters in neonates increased the duration of intravenous catheter patency (p = .0001) without increased risks of bleeding, infection, phlebitis, or extravasation injury. To determine whether percutaneously inserted central venous catheters (PICC) and peripheral intravenous catheters (PIV) in infants with very low birth weight (VLBW) differ with respect to (1) incidence of sepsis, (2) number of insertion attempts and catheters required for total intravenous therapy, (3) courses of antibiotics, and (4) total duration of intravenous (IV) use.
                A randomized comparative trial was conducted involving 63 VLBW infants (<1,251 g) who required IV therapy. Infants were assigned randomly at 1 week of age to either a PIV or a PICC catheter and followed up prospectively until an IV was no longer required or the infant was transferred out of the neonatal intensive care unit.
                Data were analyzed on an intention-to-treat basis. There was no difference in the incidence of sepsis (P = .64), number of courses of antibiotics (P = .16), or total duration of IV use (P= .34) between the 2 groups. The number of insertion attempts required for total IV therapy was significantly lower in the PICC group than in the PIV group (P = .008). There also was a significantly lower number of total catheters utilized in the PICC group (P = .002). When data were controlled for birth weight strata the results were similar.
                PICC lines reduced the number of painful IV procedures in VLBW infants without additional morbidity. Postoperative infection is an important complication after insertion of a ventriculoperitoneal (VP) shunt in children with hydrocephalus. A randomized double-blind placebo-controlled study was performed to determine the efficacy of cephalothin in preventing postoperative shunt infection. Sixty-three children who presented for elective VP shunt insertion between January 1982 and December 1985 and who did not have a history of shunt infections were randomly assigned to receive four doses of prophylactic cephalothin, 25 mg/kg (32 patients), or of a multivitamin placebo (31 patients). Postoperative infection developed in 6% of the treatment group, compared with 10% of the placebo group, a difference that was not statistically significant, although a clinical significance may have been masked by the small sample size. A large multicentre trial is needed to determine the efficacy of antibiotic prophylaxis in reducing the incidence of postoperative VP shunt infections. To determine the effects of saline, heparin 2 units (U) per ml saline, and heparin 10 U/ml saline flush solutions on the duration of intravenous (i.v.) locks and the incidence of i.v. infiltration in neonates.
                Randomized double-blind experiment.
                Tertiary-care nursery.
                Neonates (N = 90) hospitalized at birth in the intensive, intermediate care, or newborn units.
                Total hours from the time the i.v. was inserted to the time the i.v. was removed; hours from the time the i.v. was first flushed to the time the i.v. was removed; number of i.vs. removed because of infiltration.
                No statistical or clinical differences between the three groups for duration of i.v. nor for incidence of complications.
                The use of heparin in i.v. lock flush solution did not affect the duration of i.v. locks nor the incidence of infiltration in neonates. Extremely low birth weight (ELBW) infants are at risk for hypotension. Abnormal adrenal function may play a role in the pathogenesis of hypotension, and therefore, the administration of hydrocortisone (HC) may be an effective treatment for hypotension in some infants. However, the efficacy of prophylactic HC to prevent the use of vasopressors for a defined hypotensive state has not been studied. We conducted a randomized-controlled trial to determine the potential role on adrenal insufficiency in early neonatal hypotension and to determine the effectiveness of prophylactic HC in reducing treatment of hypotension in ELBW infants.
                Infants were assigned to receive either HC or placebo within the first 3 hours of life. Therapy was continued for 5 days. The presence of hypotension was based on an operational definition and treatment with vasopressors (VP) was standardized based on an a priori protocol.
                A total of 34 patients were enrolled. Baseline characteristics were similar between groups. Of the HC group 25% received VP at 24 hours of age compared to 44% of the placebo group. On day of life 2, only 7% of the HC group received VP compared to 39% of the placebo group (p<0.05).
                Prophylactic treatment with HC reduces the incidence of hypotension, defined by treatment with VP, among ELBW infants during the first 2 days of life. However, the mounting evidence that prophylactic administration of glucocorticoids in the first days of life is harmful to ELBW infants makes HC prophylaxis unwise until the efficacy of treatment relative to safety can be clearly established. The study set out to determine the survival times of peripheral total parenteral nutrition (TPN) infusion sites in neonates using a prospective, single blind, randomised trial design. The effects of various concentrations of co-administered heparin was measured using survival analysis, and of other continuous variables using multivariate analysis, against a non-heparinized control group. The study was conducted in special care baby unit located within a specialist maternity hospital in London, United Kingdom. Heparin at 0.1, 0.25, 0.5 and 1 IU/ml was added to TPN infusions delivered through peripheral veins and the survival times of the infusions determined. For infusion sites receiving heparinized fluids, the relative risk of failure decreased and the median survival time increased as the heparin concentration increased, with a maximal effect at a heparin concentration of 0.5 IU/ml (P < 0.001). Multivariate analysis using the Cox proportional hazard model confirmed the efficacy of heparin and highlighted a history of infusion therapy and the co-administration of gentamicin (from a range of drugs analysed) as being risk factors associated with infusion site failure.
                Intravenous infusion survival time can be prolonged using heparin additive at an optimal concentration of 0.5 IU/ml. This should also be of additional interest to paediatricians as heparin is an ubiquitous drug on neonatal units and its clinical use needs to be rationalised.
Prophylactic use of heparin for peripherally placed PCVC allows a greater number of infants to complete their intended use (complete therapy) by reducing occlusion. Evidence from this systematic review support the prophylactic use of heparin for PCVC in neonates. None of these studies was powered to evaluate a lower incidence rate of adverse events. If this therapy is adopted in routine practice, monitoring of side effects is indicated.