---
title: Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure
nct_id: NCT05922488
overall_status: COMPLETED
phase: NA
sponsor: Ain Shams University
study_type: INTERVENTIONAL
primary_condition: Ductus Arteriosus
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05922488.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05922488"
ct_last_update_post_date: 2023-06-28
last_seen_at: "2026-05-12T06:15:11.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure

**Official Title:** Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants on Cerebral Oxygenation and Ductus Arteriosus Closure

**NCT ID:** [NCT05922488](https://clinicaltrials.gov/study/NCT05922488)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Ain Shams University
- **Conditions:** Ductus Arteriosus
- **Start Date:** 2021-12-01
- **Completion Date:** 2023-04-20
- **CT.gov Last Update:** 2023-06-28

## Brief Summary

All patients will be subjected to the following:

1-Umbilical cord milking or delayed cord clamping according to the ranamization table 2 serial measurement of cerebral tissue oxygenation 3- serial echocardiography for ductus arteriosus (DA)functional closure

## Detailed Description

* Study Population: neonates born and admitted to Ain shams university neonatal intensive care units (NICUs).

  * Inclusion criteria:

    o Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs.
  * Exclusion criteria:

    * Late preterm with gestational age 34-37 weeks.
    * Term infants with gestational age \> 37 weeks.
    * NIRS data that was not obtained within 1st hour after birth.
    * Congenital heart disease (other than DA or small atrial septal defects/patent foramen oval/ventriculi septal defects).
    * Hypoxic-ischemic insult.
    * Major congenital deformations. #All participants will be subjected to the following:
* Infants will be considered to be randomized at the time of enrolment for:

  o Delayed cord clamping (DCC) and Umbilical cord milking (UCM)
* Near-infrared spectroscopy (NIRS):

  * In the delivery room: after the intervention (UCM or DCC) the regional cerebral tissue oxygenation (rScO2 ) and cerebral fractional tissue oxygen extraction (c FTOE) will be collected for 10 minutes within 1st hour after birth.
  * In the neonatal intensive care unit: NIRS data will be collected for 2 hours at 12,24 hours, and 48 hours after birth.
* Echocardiography:

will be performed at 6, 12, 18, 24, and 48 hours of life by using an ultrasound Doppler machine Mindary.M9. assessment of DA functioning closure by measuring duct diameter and direction of blood flow through it.

## Eligibility

- **Maximum age:** 48 Hours
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs.

Exclusion Criteria:

* Late preterm with gestational age 35-37 weeks.

  * Term infants with gestational age \> 37weeks.
  * NIRS data that not obtained within 1sthour after birth.
  * Congenital heart disease (other than PDA or small atrial septal defects/patent foramen oval/muscularventriculoseptal defects).
  * Hypoxic-ischemic insult.
  * Major congenital deformations.
```

## Arms

- **Umbilical cord milking** (EXPERIMENTAL) — In the cesarean section or vaginal delivery, the obstetrician will gently grasp the uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.
- **delayed cord clamping** (EXPERIMENTAL) — In the cesarean section or vaginal delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord. Infants will be dried and will be given gentle tactile stimulation to promote the respiratory effort.

## Interventions

- **Umbilical cord milking** (PROCEDURE) — Umbilical cord milking : uncut umbilical cord and squeeze it from the placenta several times toward the infant usually within 20 seconds.
- **delayed cord clamping** (PROCEDURE) — delayed cord clamping: delivery the delivering obstetrician will wait at least 60 s before clamping the umbilical cord

## Primary Outcomes

- **time of functional ductus arteriosus closure** _(time frame: 6, 12, 18, 24, and 48 hours of life)_ — performed by follow-up echocardiography using machine Mindary.M9 measuring changes from the baseline blood flow direction through the ductus arteriosus (DA) at 6, 12, 18, 24, 48 hours of life that helps to determine at which time the functional closure of ductus arteriosus occurs.

## Secondary Outcomes

- **changes in cerebral tissue oxygenation by NIRS.** _(time frame: First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life)_
- **ductus arteriosus diameter** _(time frame: 6, 12, 18, 24, and 48 hours of life)_

## Locations (1)

- Ainshams university, Cairo, Egypt

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ainshams university|cairo||egypt` — added _(2026-05-12)_

---

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