Early compared to delayed umbilical cord clamping in very small prematurely born babies: A study to know which one is better for infant health

• Register: ISRCTN
• Last refreshed on: 18 December 2017
• Main ID: ISRCTN12219110
• Date of registration: 11/04/2017
• Prospective Registration: No
• Primary sponsor: Centro Rosarino de Estudios Perinatales
• Public title: Early compared to delayed umbilical cord clamping in very small prematurely born babies: A study to know which one is better for infant health
• Scientific title: Early versus delayed umbilical cord clamping in preterm infants born at less than 31 weeks of gestational age: A multicenter randomized controlled trial
• Date of first enrolment: 19/08/2016
• Target sample size: 700
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN12219110
• Study type: Interventional
• Study design: Multi-centre randomised controlled clinical trial (Prevention)

Countries of recruitment

Argentina

Contacts

• Name: Guillermo Carroli

Key inclusion & exclusion criteria

Inclusion criteria: 1. Singleton pregnant women
2. Aged 14 years and older
3. Vaginal or cesarean section delivery
4. Informed consent granted
5. Gestation period between 24 and 30 weeks and six days
Exclusion criteria: 1. Congenital malformations or genetic syndrome (antenatal diagnosis or in the delivery room)
2. Rh-sensitized pregnant women

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Sepsis
Pregnancy and Childbirth
Sepsis

Intervention(s)

Participants are randomly allocated to one of two groups. Randomisation is done using a random generator by a statistical software. Randomisation is performed centrally and is stratified for each of the participating centres. Allocation concealment is ensured by using sequentially numbered, sealed and opaque envelopes containing the assigned intervention. All participants receive the standard care while giving birth (either vaginally or through a caesarean section).

Group 1: This group receives early umbilical cord clamping 30 seconds after birth. The clamping is done the standard level of care.

Group 2: This group receives delayed umbilical cord clamping 90 seconds after birth. The clamping is done to the standard level of care.

The timing of the umbilical cord clamping is measured using a stopwatch by an independent observer who is not in charge of any specific task of care at the time of birth.

The babies are followed up for incidence of illness and sepsis during hospitalisation with clinical exams, blood samples and x-rays up until they are discharged from the hospital. Mothers are followed up for blood loss during birth and until discharge from the hospital.

Primary Outcome(s)

1. Proven sepsis rates in new born infants is measured on the basis of clinical condition compatible with positive blood and/or cerebrospinal fluid and/or urine cultures (urine must be obtained by urethral catheterization or bladder puncture) at three days after birth and up until discharge from the hospital
2. Very probable sepsis rates in new born infants is measured on the basis of clinical signs of sepsis, negative cultures, antibiotic treatment equal or greater than seven days and two or more of the following diagnostic test results: <5000 white blood cells/mm3, <1500 neutrophils/mm3, Immature-to-Total-Neutrophil (I/T) Ratio (IN/TN): 0.2, C-reactive protein >10mg/L, <100,000 platelets/mm3, at three days after birth and up until discharge from the hospital

Secondary Outcome(s)

Infant outcomes:
1. Health at birth is measured using the Apgar scale at one and five minutes after birth
2. Assistance at birth is measured using time of first breath and need for bag mask-ventilation at hospital discharge
3. Intracranial hemorrhage is measured using brain ultrasonography following Papille´s classification (grades 1-4) at 24-48 hours after birth
4. Respiratory distress syndrome (RDS) using clinical indicators and chest x-rays at any time before discharge from the hospital
5.Symptomatic patent ductus arteriosus (PDA) is measured using echocardiography at any time before discharge form the hospital
6. Necrotizing enterocolitis (NEC) is measured using clinical and radiological findings according to Bell´s staging criteria at any time before discharge from the hospital
7. Bronchopulmonary dysplasia (BPD) is measured using clinical and radiological findings at any time before discharge from the hospital
8. Retinopathy of prematurity (ROP) is measured using alterations compatible with retinal grades at any time before discharge from the hospital
9. Death is measured through patient records at occurrence moment
10. Neurodevelopment is measured using Bayley scales at 18-24 months of age
11. Central packed cell volume are measured using blood samples at 6 and 24 hours after birth
12. Plasma bilirubin level are measured using blood samples at 24, 72 and 120 hours after birth
13. Plasma ferritin level are measured using blood samples at discharge from hospital
14. White blood cell count and C-reactive protein (CRP) in preterm infants with suspected sepsis are measured using blood samples at any time before discharge from the hospital
15. Blood pressure is measured using blood pressure cuffs at 2, 6,12 and 24 hours after birth

Maternal outcomes:
1. The proportion of women with blood loss of 500 mL or more is measured by collecting blood loss at one hour postpartum (or two hours postpartum if the bleeding continues beyond one hour)
2. The proportion of women with blood loss of 1000 mL or more is measured by collecting blood loss at one hour postpartum (or two hours postpartum if the bleeding continues beyond one hour)
3. Maternal blood loss in mL is measured by collecting blood loss at one hour postpartum (or two hours postpartum if the bleeding continues beyond one hour)

Secondary ID(s)

2/16

Source(s) of Monetary Support

Pan American Health Organisation (PAHO), Paediatric Hospital Foundation- The Garrahan Foundation