Early Versus Delayed Cord Clamping at Term: Neurodevelopmental Outcomes in Swedish Infants at 4 Years of Age - Full Text View

Purpose

Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared to early clamping, a delay in clamping in clamping of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight to the newborn infant.

The results of previous intervention studies on delayed clamping are mixed, and few have followed the infants beyond the perinatal period. All longer follow up studies have been performed in low income countries except for the investigators earlier study, showing less iron deficiency and improved iron stores after delayed cord clamping at 4 months of age.

The main objective of the current study is to assess whether the time of cord clamping affects neurodevelopment at 4 years of age in a large sample of full-term, Swedish infants. The investigators hypothesis is that as delayed cord clamping improves iron stores at 4 months, this could affect the child's development positively.

Condition	Intervention
Developmental Delay Iron Deficiency	Procedure: Time to clamping of the umbilical cord after delivery

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Early Versus Delayed Cord Clamping at Term: Neurodevelopmental Outcomes in Swedish Infants at 4 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Iron

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:

Intelligence quotient (IQ) as measured by the Wechsler Preschool and Primary Scale of Intelligence-III. [ Time Frame: 48 months (plus 3 months) ] [ Designated as safety issue: No ]
The Wechsler Preschool and Primary Scale of Intelligence (WPPSI) is an intelligence test designed for children ages 2 years 6 months to 7 years 3 months. A trained and experienced psychologist will perform the test and do the evaluation.

Secondary Outcome Measures:

Score of the different subsets of Wechsler Preschool and Primary Scale of Intelligence-III. [ Time Frame: 48 months (plus 3 months) ] [ Designated as safety issue: No ]
The subsets of the Wechsler Preschool and Primary Scale include Verbal and Performance IQ; the Processing Speed Quotient and a General Language Composite. Each subset will result in a score, the difference between the intervention groups will be assessed with an appropriate statistical method
Psychomotor development assessed by the Ages and Stages Questionnaire. [ Time Frame: 48 months (plus 3 months) ] [ Designated as safety issue: No ]
Ages and Stages Questionnaire is a parent report questionnaire available for developmental screening of children from one month to 5 ½ years. 30 questions are divided into 5 developmental domains (communication, gross motor, fine motor, problem solving and personal-social). Total score and scores within separate domains from the 48-month questionnaire will be assessed.
Fine motor skills assessed by the Movement Assessment Battery for Children-Second Edition. [ Time Frame: 48 months (plus 3 months) ] [ Designated as safety issue: No ]
The Performance Test of the the Movement Assessment Battery for Children contains 8 tasks. The tasks cover the following 3 areas: manual dexterity (3 items), ball skills (2 items), and static and dynamic balance (3 items). A psychologist will observe and record how the child performs the tasks.
Behaviour assessed by the Strengths and Difficulties Questionnaire or it's subscales. [ Time Frame: 48 months (plus 3 months) ] [ Designated as safety issue: No ]
All versions of the SDQ ask about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales:emotional symptoms (5 items), conduct problems (5 items), hyperactivity/inattention (5 items) and peer relationship problems (5 items) added together to generate a total difficulties score (based on 20 items) and a separate scale concerning prosocial behavior (5 items).
Gender effect on the result of the developmental tests. [ Time Frame: 48 months (plus 3 months) ] [ Designated as safety issue: No ]
All results from WPPSI-III, ASQ, SDQ and Movement ABC will be statistically analysed to evaluate if the combination of gender and timing of cord clamping will affect the results.
Gestational age effect on the result of the developmental tests. [ Time Frame: 48 months (plus 3 months) ] [ Designated as safety issue: No ]
All results from WPPSI-III, ASQ, SDQ and Movement ABC will be statistically analysed to evaluate if the combination of gender and timing of cord clamping will affect the results.

Estimated Enrollment:	350
Study Start Date:	April 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Early cord clamping (ECC) Early cord clamping consisted of early (=< 10 s) clamping of the umbilical cord at birth.	Procedure: Time to clamping of the umbilical cord after delivery The time after delivery of the newborn until the midwife stops the circulation in the umbilical cord with a clamp. Other Names: Immediate cord clamping Late cord clamping Deferred cord clamping
Delayed cord clamping (DCC) Delayed cord clamping consisted of delayed (>= 180 s) clamping of the umbilical cord at birth.	Procedure: Time to clamping of the umbilical cord after delivery The time after delivery of the newborn until the midwife stops the circulation in the umbilical cord with a clamp. Other Names: Immediate cord clamping Late cord clamping Deferred cord clamping

Show Detailed Description

Eligibility

Ages Eligible for Study:	48 Months to 51 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The eligble population consists of a group of 382 children who were included in a trial (NCT01245296) and randomized to either early or delayed cord clamping. The parents will be asked for consent for their child to participate in the current follow up study.

Criteria

Inclusion Criteria:

Participant in the earlier cord clamping trial
Age between 48 and 51 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581489

Contacts

Contact: Ola Andersson, MD	+46 (0)35 13 40 93	ola.k.andersson@regionhalland.se
Contact: Lena Hellström-Westas, MD, PhD	+46 18 611 48 77	lena.westas@kbh.uu.se

Locations

Sweden
Hospital of Halland, Halmstad	Recruiting
Halmstad, Halland, Sweden, 301 85
Contact: Ola Andersson, MD 46709664180 ola.k.andersson@regionhalland.se
Principal Investigator: Ola Andersson, MD
Principal Investigator: Barbro Lindquist, PhD

Sponsors and Collaborators

Uppsala University

Umeå University

Halmstad County Hospital

County Council of Halland, Sweden

Investigators

Principal Investigator:	Ola Andersson, MD	Hospital of Halland, Halmstad
Principal Investigator:	Barbro Lindquist, PhD	Hospital of Halland, Halmstad
Study Chair:	Lena Hellström-Westas, Professor	Uppsala University

More Information

Publications:

Andersson O, Hellström-Westas L, Andersson D, Domellöf M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ. 2011 Nov 15;343:d7157.

Responsible Party:	Uppsala University
ClinicalTrials.gov Identifier:	NCT01581489 History of Changes
Other Study ID Numbers:	NATIBAR1213
Study First Received:	March 13, 2012
Last Updated:	April 20, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:

Cord clamping
iron deficiency
Neurodevelopment

Additional relevant MeSH terms:

Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia

Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 17, 2012