MOCC Group for Premature Birth

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
IWK Health Centre, Halifax, Canada
Premature Birth+1 More
MOCC Group - Procedure
Eligibility
< 18
All Sexes
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Study Summary

This study is evaluating whether a new approach to cord clamping (milking the cord) might improve the health of preterm infants.

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Eligible Conditions

  • Premature Birth
  • Preterm, Infant

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether MOCC Group will improve 3 primary outcomes, 1 secondary outcome, and 8 other outcomes in patients with Premature Birth. Measurement will happen over the course of From randomization assessed up to 2 hours of age.

24 Months Corrected age
Long-term outcomes
Hour 24
Compare hemoglobin (Hgb) concentration
Hour 2
Need for advanced resuscitation at birth
Temperature stability
Week 36
Intraventricular hemorrhage (IVH)
Week 36
Blood transfusion
Hour 72
Cerebral oxygenation
Inotropic support
Volume expander
Year 5
Number of adverse events associated with the MOCC intervention
Two years
Number of patients completing the study
Rate of compliance to the study intervention

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

DCC group
1 of 2
MOCC Group
1 of 2
Active Control
Experimental Treatment

This trial requires 98 total participants across 2 different treatment groups

This trial involves 2 different treatments. MOCC Group is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

MOCC Group
Procedure
The OB provider will hold the baby at/below the placenta, provide warmth, stimulate the baby and suction the mouth/nose for 30 secs.S/He will then clamp and cut the cord about 5 cm from the the introitus (vaginal deliveries) or from the abdominal incision (C-Sections) before handing the baby with the long-cut cord to the neonatal team to resuscitate/ stabilize the baby. A member of the neonatal team will milk the long-cut cord slowly 1 time from the cut end toward the infant over 10 secs before clamping and cutting the cord 1-2 cm from the umbilical stump. The neonatal team will provide PPV to the baby (during the milking process) if the baby is not breathing. If the baby is breathing during the milking process the team will continue the stabilization as per standard NRP practice.
DCC group
Procedure
The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds. After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: till the participants reach 2 year- corrected age (around 4.5 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly till the participants reach 2 year- corrected age (around 4.5 years) for reporting.

Who is running the study

Principal Investigator
W. E.
Prof. Walid El-Naggar, Principle Investigator, Associate Professor of Pediatrics
IWK Health Centre

Closest Location

IWK Health Centre - Halifax, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Preterm infants <32 weeks' gestation

Patient Q&A Section

What causes premature birth?

"In the United States, premature birth is more common than in the developed world, but the reasons behind high rates in the United States are not well understood. Improving access to quality prenatal care and access to emergency and specialty prenatal care may help to prevent premature birth in the United States." - Anonymous Online Contributor

Unverified Answer

What are common treatments for premature birth?

"Doctors often recommend that mothers stop taking drugs with teratogenic (birth defects causing) tendencies, such as alcohol, and nicotine, in some patients who give birth prematurely, unless they have a congenital condition such as Down syndrome. There is no compelling evidence that stopping the drugs can prevent premature birth, nor does evidence suggest that stopping the drugs once the baby is born could prevent the problems they cause. Doctors recommend stopping smoking in pregnancy because smoking greatly increases the risk of premature birth but does not necessarily cause it." - Anonymous Online Contributor

Unverified Answer

Can premature birth be cured?

"Findings from a recent study demonstrated the feasibility and efficacy of this treatment protocol. The combination of prenatal care in high-risk women, intrauterine administration of methylphenidate, and early delivery is a reasonable treatment for premature birth." - Anonymous Online Contributor

Unverified Answer

What are the signs of premature birth?

"In premature infants, respiratory signs such as a cyanotic heart and a coarse flush may be present. PNAH is often present, and an enlarged liver may be found in premature infants. A decreased birthweight suggests the likelihood of premature birth. Birth defects and low birthweight (<5000 g or <2.5 lb) in the first 2 weeks after birth may be detectable by signs such as a small head and face, low muscle tone and jaundice." - Anonymous Online Contributor

Unverified Answer

What is premature birth?

"The word premature may be somewhat misleading because there are no single guidelines available for the medical care of extremely premature newborns. Each premature is different and requires individualized management throughout the neonatal period of extreme prematurity. Many neonatologists continue to practice in the NICU for the newborn era on a case-by-case basis and in addition may be involved in primary pediatric care of the premature infant. In addition, many parents want to maintain a close interaction with their newborn infant throughout the preoperative and surgical procedures and want to know the status of their newborn infant at any given time." - Anonymous Online Contributor

Unverified Answer

How many people get premature birth a year in the United States?

"Approximately 1.4 million infants are born every year prematurely in the U.S.; approximately half (52%) of them are non-Hispanic black. Preterm birth imposes a significant public health burden by increasing neonatal mortality and healthcare utilization." - Anonymous Online Contributor

Unverified Answer

Does mocc group improve quality of life for those with premature birth?

"Recent findings support the value of the group-based intervention to the QoL of parents of infants with very low birthweight ≥ 32 lb (13 kg < 2 lb)." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of mocc group?

"Mocc group has many side effects and it should be taken cautiously. These can be divided into two kinds: long-term side effects and short-term side effects. Long-term side effects include headache, dizziness, fever, vomiting, nausea and fatigue. Short-term side effects include itchiness, burning sensation, and other hypersensitivity of the skin. As for long-term side effects, headache is the most commonly reported, because it is easy to develop headaches or migraine from use of mocc group. Besides that, vomiting and dizziness can become serious and lead to some special medication which is important to pay special attention to." - Anonymous Online Contributor

Unverified Answer

Does premature birth run in families?

"Preterm birth did not appear to run in families of women with either SPTB or EPTD. Birth control should be emphasized in at-risk couples planning pregnancy and is one facet of the FESP intervention, which warrants further study." - Anonymous Online Contributor

Unverified Answer

How serious can premature birth be?

"Premature birth may negatively affect the mother and infant. The consequences of this vary by the type of premature birth and the amount of birth defects. Physicians may advise mothers of children born prematurely to avoid breastfeeding their infants. Parents of infants born prematurely need to be aware that they could be at risk for birth defects, and should be educated about the risks." - Anonymous Online Contributor

Unverified Answer

Is mocc group typically used in combination with any other treatments?

"We have found no clinical studies confirming any beneficial effect of mocc treatment, though there is evidence of the potential of mocc for reducing the incidence of postoperative pain. In most studies, mocc was used in combination with anti-emetics, analgesics, and topical treatments. Data from a recent study further illuminate the need to evaluate mocc as an independent treatment modality for patients with postoperative pain." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating premature birth?

"Until now, no new therapeutics for premature birth have been approved. For the time being the only known treatments for premature birth are to take the baby out of the birth canal and to reduce the risk of complications (e.g. hypoxic-ischemic encephalopathy, lung disease). However, new research is showing that it is possible to treat premature birth with a number of new drugs. For instance, a recent study shows that the use of the anti-inflammatory drug salbutamol can reduce the mortality from premature birth by two thirds (e.g. https://dsmz.org/en/research/albatross.html)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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